The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741792
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : July 27, 2015
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-cell Lymphoma
Intervention Drug: Blinatumomab
Enrollment 25
Recruitment Details

Adults with a diagnosis of diffuse large B-cell lymphoma (DLBCL) which was refractory to first or subsequent treatment or who had a first or later relapse and were not eligible for autologous hematopoietic stem cell transplant (HSCT), or relapsed after autologous HSCT were eligible to enrol.

The primary analysis cut-off date was 10 July 2014.
Pre-assignment Details The study was conducted sequentially in 2 stages and 3 cohorts: In Stage 1, Cohort 1 received an escalating dose of 9/28/112 µg/day blinatumomab and Cohort 2 received a constant dose of 112 µg/day for 8 weeks. In Stage 2, the Cohort 3 dose regimen was determined from the outcome of Cohorts 1 and 2.
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d
Hide Arm/Group Description Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Period Title: Overall Study
Started 9 [1] 2 [2] 14
Efficacy Set 7 [3] 1 [3] 13 [3]
Completed 3 1 2
Not Completed 6 1 12
Reason Not Completed
Death             6             1             12
[1]
3 participants were not considered evaluable and were replaced as specified in the protocol.
[2]
Cohort 2 was closed to enrollment on recommendation of the data monitoring committee
[3]
Completed > 7 days of infusion on the highest intended dose level or discontinued due to progression
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d Total
Hide Arm/Group Description Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Total of all reporting groups
Overall Number of Baseline Participants 9 2 14 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 2 participants 14 participants 25 participants
71.7  (7.8) 64.5  (13.4) 57.1  (13.6) 62.9  (13.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 2 participants 14 participants 25 participants
Female
7
  77.8%
0
   0.0%
4
  28.6%
11
  44.0%
Male
2
  22.2%
2
 100.0%
10
  71.4%
14
  56.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 9 participants 2 participants 14 participants 25 participants
9 2 14 25
Relapsed/refractory Status to Last Prior Treatment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 9 participants 2 participants 14 participants 25 participants
Relapsed 4 1 4 9
Refractory 5 1 10 16
Number of Previous Autologous Hematopoietic Stem Cell Transplants (HSCT)  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 9 participants 2 participants 14 participants 25 participants
None 7 1 10 18
≥ 1 2 1 4 7
1.Primary Outcome
Title Overall Objective Response Rate During Treatment Cycle 1
Hide Description

Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.
Time Frame During the first 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 7 1 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.1
(18.4 to 90.1)
100.0
(2.5 to 100.0)
30.8
(9.1 to 61.4)
2.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Response
Hide Description Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.
Time Frame During the first 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 7 1 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.6
(3.7 to 71.0)
0
(0.0 to 97.5)
15.4
(1.9 to 45.4)
3.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of Partial Response
Hide Description Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (<50% decrease in size of masses) of measureable disease and no new sites.
Time Frame During the first 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 7 1 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.6
(3.7 to 71.0)
100.0
(2.5 to 100.0)
15.4
(1.9 to 45.4)
4.Secondary Outcome
Title Duration of Objective Response
Hide Description The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Time Frame From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set with an overall objective response of CR or PR during the first treatment cycle
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 4 1 4
Median (95% Confidence Interval)
Unit of Measure: months
8.7 [1] 
(0.9 to NA)
NA [1] 
(NA to NA)
4.0 [1] 
(1.9 to NA)
[1]
Could not be estimated due to the low number of events
5.Secondary Outcome
Title Duration of Complete Response
Hide Description The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Time Frame From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set with a best overall response of CR during the first treatment cycle
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 2 0 2
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(11.6 to NA)
NA [1] 
(5.9 to NA)
[1]
Could not be estimated due to the low number of events
6.Secondary Outcome
Title Duration of Partial Response
Hide Description The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Time Frame From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set with a best overall response of PR during the first treatment cycle
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 2 1 2
Median (95% Confidence Interval)
Unit of Measure: months
3.3
(0.9 to 5.8)
NA [1] 
(NA to NA)
2.0
(1.9 to 2.1)
[1]
Could not be estimated due to the low number of events
7.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.
Time Frame From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 7 1 13
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(0.7 to 14.1)
NA [1] 
(NA to NA)
1.6
(0.6 to 4.6)
[1]
Could not be estimated due to the low number of events
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.
Time Frame From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy set
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 7 1 13
Median (95% Confidence Interval)
Unit of Measure: months
20.1 [1] 
(2.3 to NA)
NA [1] 
(NA to NA)
3.6
(1.5 to 14.8)
[1]
Could not be estimated due to the low number of events
9.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

An adverse event or suspected adverse drug reaction was considered "serious" if it resulted in one of the following outcomes:

  • Resulted in death;
  • Was life-threatening;
  • Required inpatient hospitalization or prolongation of existing hospitalization;
  • Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;
  • Was a congenital anomaly or birth defect;
  • Was a medically important condition.

The Investigator used medical judgment to determine whether there was a causal relationship (ie, related [reasonably possible] or unrelated [not reasonably possible]) between an adverse event and blinatumomab.
Time Frame From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 μg/d Cohort 2: Blinatumomab 112 μg/d Cohort 3: Blinatumomab 9/28/112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
Overall Number of Participants Analyzed 9 2 14
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 9 2 14
AE of Grade ≥ 3 9 2 13
AE of Grade ≥ 4 0 2 6
Serious adverse event (SAE) 9 2 12
Fatal adverse events 0 0 2
Led to discontinuation of study drug 3 1 2
Led to interruption of study drug 4 1 6
Related adverse events 9 2 11
Related AE Grade ≥ 3 5 2 5
Related AE Grade ≥ 4 0 1 2
Serious related adverse events 5 2 3
Related AE led to discontinuation of study drug 2 1 2
Related AE led to interruption of study drug 3 1 3
10.Secondary Outcome
Title Blinatumomab Steady State Serum Concentration
Hide Description Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.
Time Frame Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).
Arm/Group Title Blinatumomab 9 μg/d Blinatumomab 28 μg/d Blinatumomab 112 μg/d
Hide Arm/Group Description:
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
Participants received blinatumomab CIV 28 µg/day.
Participants received blinatumomab administered CIV 112 µg/day.
Overall Number of Participants Analyzed 20 16 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
277  (210) 565  (208) 2800  (1150)
11.Secondary Outcome
Title Leukocyte Counts
Hide Description Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 6.376  (3.284)
Day 1 Prior (N = 24) 5.729  (2.891)
Day 8 (N = 21) 6.819  (3.201)
Day 15 (N = 16) 6.400  (2.486)
Day 29 (N = 11) 3.764  (2.160)
Day 43 (N = 8) 4.950  (3.819)
End of Infusion (N = 9) 4.611  (2.114)
End of Core Study (N = 6) 6.850  (2.818)
3-Month Follow-up (N = 5) 4.820  (1.616)
6-Month Follow-up (N = 6) 5.183  (1.380)
9-Month Follow-up (N = 4) 4.425  (0.854)
12-Month Follow-up (N = 4) 5.700  (1.424)
15-Month Follow-up (N = 3) 4.767  (0.874)
18-Month Follow-up (N = 3) 6.467  (1.779)
21-Month Follow-up (N = 21) 5.450  (0.495)
24-Month Follow-up (N = 3) 4.533  (1.069)
12.Secondary Outcome
Title Lymphocyte Counts
Hide Description Lymphocyte counts were analyzed by differential blood count analysis.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.779  (0.425)
Day 1 Prior (N = 24) 0.491  (0.259)
Day 8 (N = 21) 0.382  (0.215)
Day 15 (N = 16) 0.277  (0.165)
Day 29 (N = 11) 0.472  (0.273)
Day 43 (N = 8) 0.847  (0.511)
End of Infusion (N = 9) 0.767  (0.505)
End of Core Study (N = 6) 1.060  (0.489)
3-Month Follow-up (N = 5) 1.053  (0.421)
6-Month Follow-up (N = 6) 1.120  (0.621)
9-Month Follow-up (N = 4) 1.048  (0.381)
12-Month Follow-up (N = 4) 1.120  (0.449)
15-Month Follow-up (N = 3) 0.998  (0.527)
18-Month Follow-up (N = 3) 0.565  (0.180)
21-Month Follow-up (N = 21) 1.205  (0.839)
24-Month Follow-up (N = 3) 0.737  (0.478)
13.Secondary Outcome
Title Monocyte Counts
Hide Description [Not Specified]
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.638  (0.415)
Day 1 Prior (N = 24) 0.300  (0.565)
Day 8 (N = 21) 0.202  (0.386)
Day 15 (N = 16) 0.188  (0.317)
Day 29 (N = 11) 0.318  (0.185)
Day 43 (N = 8) 0.646  (0.375)
End of Infusion (N = 9) 0.473  (0.241)
End of Core Study (N = 6) 0.711  (0.569)
3-Month Follow-up (N = 5) 0.585  (0.280)
6-Month Follow-up (N = 6) 0.487  (0.239)
9-Month Follow-up (N = 4) 0.452  (0.112)
12-Month Follow-up (N = 4) 0.469  (0.061)
15-Month Follow-up (N = 3) 0.511  (0.053)
18-Month Follow-up (N = 3) 0.290  (0.123)
21-Month Follow-up (N = 21) 0.516  (0.008)
24-Month Follow-up (N = 3) 0.234  (0.176)
14.Secondary Outcome
Title Granulocyte Count
Hide Description [Not Specified]
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 4.968  (3.187)
Day 1 Prior (N = 24) 4.910  (2.425)
Day 8 (N = 21) 6.235  (2.881)
Day 15 (N = 16) 5.935  (2.387)
Day 29 (N = 11) 2.974  (2.019)
Day 43 (N = 8) 3.457  (3.395)
End of Infusion (N = 9) 3.353  (2.134)
End of Core Study (N = 6) 5.080  (3.012)
3-Month Follow-up (N = 5) 3.182  (1.117)
6-Month Follow-up (N = 6) 3.594  (0.950)
9-Month Follow-up (N = 4) 2.925  (0.675)
12-Month Follow-up (N = 4) 4.111  (1.382)
15-Month Follow-up (N = 3) 3.258  (0.745)
18-Month Follow-up (N = 3) 5.612  (1.713)
21-Month Follow-up (N = 21) 3.729  (0.352)
24-Month Follow-up (N = 3) 3.563  (0.711)
15.Secondary Outcome
Title CD19+ B-Cell Count
Hide Description CD19+ B-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.026  (0.072)
Day 1 Prior (N = 24) 0.029  (0.085)
Day 8 (N = 21) 0.001  (0.002)
Day 15 (N = 16) 0.000  (0.001)
Day 29 (N = 11) 0.000  (0.000)
Day 43 (N = 8) 0.000  (0.001)
End of Infusion (N = 9) 0.001  (0.001)
End of Core Study (N = 6) 0.001  (0.002)
3-Month Follow-up (N = 5) 0.025  (0.026)
6-Month Follow-up (N = 6) 0.029  (0.043)
9-Month Follow-up (N = 4) 0.054  (0.066)
12-Month Follow-up (N = 4) 0.082  (0.113)
15-Month Follow-up (N = 3) 0.094  (0.118)
18-Month Follow-up (N = 3) 0.071  (0.075)
21-Month Follow-up (N = 21) 0.131  (0.170)
24-Month Follow-up (N = 3) 0.108  (0.120)
16.Secondary Outcome
Title CD19+ B-Cells as a Percentage of All Lymphocytes
Hide Description CD19+ B-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocytes
Screening (N = 25) 2  (7)
Day 1 Prior (N = 24) 4  (9)
Day 8 (N = 21) 0  (0)
Day 15 (N = 16) 0  (0)
Day 29 (N = 11) 0  (0)
Day 43 (N = 8) 0  (0)
End of Infusion (N = 9) 0  (0)
End of Core Study (N = 6) 0  (0)
3-Month Follow-up (N = 5) 2  (2)
6-Month Follow-up (N = 6) 2  (3)
9-Month Follow-up (N = 4) 5  (5)
12-Month Follow-up (N = 4) 7  (9)
15-Month Follow-up (N = 3) 7  (7)
18-Month Follow-up (N = 3) 11  (9)
21-Month Follow-up (N = 21) 8  (8)
24-Month Follow-up (N = 3) 12  (7)
17.Secondary Outcome
Title CD3+ T-Cell Count
Hide Description CD3+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.578  (0.355)
Day 1 Prior (N = 24) 0.349  (0.233)
Day 8 (N = 21) 0.282  (0.194)
Day 15 (N = 16) 0.199  (0.159)
Day 29 (N = 11) 0.348  (0.231)
Day 43 (N = 8) 0.613  (0.426)
End of Infusion (N = 9) 0.543  (0.421)
End of Core Study (N = 6) 0.825  (0.431)
3-Month Follow-up (N = 5) 0.773  (0.443)
6-Month Follow-up (N = 6) 0.782  (0.345)
9-Month Follow-up (N = 4) 0.671  (0.184)
12-Month Follow-up (N = 4) 0.703  (0.203)
15-Month Follow-up (N = 3) 0.594  (0.227)
18-Month Follow-up (N = 3) 0.298  (0.049)
21-Month Follow-up (N = 21) 0.623  (0.266)
24-Month Follow-up (N = 3) 0.456  (0.257)
18.Secondary Outcome
Title CD3+ T-Cells as a Percentage of All Lymphocytes
Hide Description CD3+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocytes
Screening (N = 25) 72  (14)
Day 1 Prior (N = 24) 68  (18)
Day 8 (N = 21) 70  (19)
Day 15 (N = 16) 67  (19)
Day 29 (N = 11) 73  (15)
Day 43 (N = 8) 71  (13)
End of Infusion (N = 9) 66  (14)
End of Core Study (N = 6) 76  (16)
3-Month Follow-up (N = 5) 73  (11)
6-Month Follow-up (N = 6) 66  (21)
9-Month Follow-up (N = 4) 66  (6)
12-Month Follow-up (N = 4) 65  (9)
15-Month Follow-up (N = 3) 61  (7)
18-Month Follow-up (N = 3) 57  (20)
21-Month Follow-up (N = 21) 58  (16)
24-Month Follow-up (N = 3) 63  (8)
19.Secondary Outcome
Title CD4+ T-Cell Count
Hide Description CD4+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.254  (0.160)
Day 1 Prior (N = 24) 0.152  (0.128)
Day 8 (N = 21) 0.131  (0.128)
Day 15 (N = 16) 0.085  (0.084)
Day 29 (N = 11) 0.170  (0.172)
Day 43 (N = 8) 0.261  (0.219)
End of Infusion (N = 9) 0.241  (0.254)
End of Core Study (N = 6) 0.375  (0.251)
3-Month Follow-up (N = 5) 0.371  (0.216)
6-Month Follow-up (N = 6) 0.371  (0.237)
9-Month Follow-up (N = 4) 0.309  (0.184)
12-Month Follow-up (N = 4) 0.399  (0.193)
15-Month Follow-up (N = 3) 0.326  (0.220)
18-Month Follow-up (N = 3) 0.178  (0.042)
21-Month Follow-up (N = 21) 0.373  (0.279)
24-Month Follow-up (N = 3) 0.258  (0.248)
20.Secondary Outcome
Title CD4+ T-Cells as a Percentage of All Lymphocytes
Hide Description CD4+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocytes
Screening (N = 25) 33  (11)
Day 1 Prior (N = 24) 28  (14)
Day 8 (N = 21) 32  (17)
Day 15 (N = 16) 29  (13)
Day 29 (N = 11) 34  (18)
Day 43 (N = 8) 30  (12)
End of Infusion (N = 9) 28  (13)
End of Core Study (N = 6) 32  (15)
3-Month Follow-up (N = 5) 33  (9)
6-Month Follow-up (N = 6) 30  (10)
9-Month Follow-up (N = 4) 31  (13)
12-Month Follow-up (N = 4) 35  (7)
15-Month Follow-up (N = 3) 31  (7)
18-Month Follow-up (N = 3) 32  (6)
21-Month Follow-up (N = 21) 29  (4)
24-Month Follow-up (N = 3) 34  (8)
21.Secondary Outcome
Title CD8+ T-Cell Count
Hide Description CD8+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.298  (0.256)
Day 1 Prior (N = 24) 0.186  (0.136)
Day 8 (N = 21) 0.134  (0.099)
Day 15 (N = 16) 0.102  (0.095)
Day 29 (N = 11) 0.140  (0.076)
Day 43 (N = 8) 0.299  (0.237)
End of Infusion (N = 9) 0.284  (0.195)
End of Core Study (N = 6) 0.438  (0.284)
3-Month Follow-up (N = 5) 0.381  (0.254)
6-Month Follow-up (N = 6) 0.403  (0.304)
9-Month Follow-up (N = 4) 0.225  (0.039)
12-Month Follow-up (N = 4) 0.310  (0.200)
15-Month Follow-up (N = 3) 0.214  (0.023)
18-Month Follow-up (N = 3) 0.105  (0.057)
21-Month Follow-up (N = 21) 0.185  (0.026)
24-Month Follow-up (N = 3) 0.187  (0.068)
22.Secondary Outcome
Title CD8+ T-Cells as a Percentage of All Lymphocytes
Hide Description CD8+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocytes
Screening (N = 25) 37  (18)
Day 1 Prior (N = 24) 37  (19)
Day 8 (N = 21) 35  (19)
Day 15 (N = 16) 35  (17)
Day 29 (N = 11) 33  (17)
Day 43 (N = 8) 37  (15)
End of Infusion (N = 9) 36  (16)
End of Core Study (N = 6) 43  (23)
3-Month Follow-up (N = 5) 36  (19)
6-Month Follow-up (N = 6) 34  (16)
9-Month Follow-up (N = 4) 25  (11)
12-Month Follow-up (N = 4) 28  (13)
15-Month Follow-up (N = 3) 24  (9)
18-Month Follow-up (N = 3) 21  (13)
21-Month Follow-up (N = 21) 20  (12)
24-Month Follow-up (N = 3) 27  (16)
23.Secondary Outcome
Title CD19+ B-Cell to CD3+ T-Cell Ratio
Hide Description CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ratio
Screening (N = 25) 0.04  (0.15)
Day 1 Prior (N = 24) 0.07  (0.24)
Day 8 (N = 21) 0.00  (0.01)
Day 15 (N = 16) 0.00  (0.00)
Day 29 (N = 11) 0.00  (0.00)
Day 43 (N = 8) 0.00  (0.00)
End of Infusion (N = 9) 0.00  (0.01)
End of Core Study (N = 6) 0.00  (0.00)
3-Month Follow-up (N = 5) 0.03  (0.03)
6-Month Follow-up (N = 6) 0.04  (0.05)
9-Month Follow-up (N = 4) 0.08  (0.08)
12-Month Follow-up (N = 4) 0.12  (0.15)
15-Month Follow-up (N = 3) 0.13  (0.13)
18-Month Follow-up (N = 3) 0.25  (0.30)
21-Month Follow-up (N = 21) 0.17  (0.20)
24-Month Follow-up (N = 3) 0.19  (0.13)
24.Secondary Outcome
Title CD4+ T-Cell to CD8+ T-Cell Ratio
Hide Description CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ratio
Screening (N = 25) 1.32  (1.19)
Day 1 Prior (N = 24) 1.16  (1.45)
Day 8 (N = 21) 1.20  (0.96)
Day 15 (N = 16) 1.03  (0.71)
Day 29 (N = 11) 1.43  (1.08)
Day 43 (N = 8) 0.96  (0.53)
End of Infusion (N = 9) 1.09  (1.00)
End of Core Study (N = 6) 1.03  (0.80)
3-Month Follow-up (N = 5) 1.18  (0.79)
6-Month Follow-up (N = 6) 1.10  (0.70)
9-Month Follow-up (N = 4) 1.53  (1.25)
12-Month Follow-up (N = 4) 1.70  (1.47)
15-Month Follow-up (N = 3) 1.47  (0.81)
18-Month Follow-up (N = 3) 2.23  (1.70)
21-Month Follow-up (N = 21) 1.85  (1.34)
24-Month Follow-up (N = 3) 1.73  (1.21)
25.Secondary Outcome
Title CD4+ Naive T Cell Count
Hide Description CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.028  (0.056)
Day 1 Prior (N = 24) 0.013  (0.022)
Day 8 (N = 21) 0.014  (0.033)
Day 15 (N = 16) 0.012  (0.024)
Day 29 (N = 11) 0.032  (0.071)
Day 43 (N = 8) 0.036  (0.060)
End of Infusion (N = 9) 0.037  (0.088)
End of Core Study (N = 6) 0.050  (0.083)
3-Month Follow-up (N = 5) 0.015  (0.019)
6-Month Follow-up (N = 6) 0.023  (0.044)
9-Month Follow-up (N = 4) 0.053  (0.090)
12-Month Follow-up (N = 4) 0.053  (0.084)
15-Month Follow-up (N = 3) 0.044  (0.059)
18-Month Follow-up (N = 3) 0.035  (0.041)
21-Month Follow-up (N = 21) 0.098  (0.103)
24-Month Follow-up (N = 3) 0.016  (0.013)
26.Secondary Outcome
Title CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Hide Description CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD4+ T-cells
Screening (N = 25) 8  (9)
Day 1 Prior (N = 24) 7  (7)
Day 8 (N = 21) 7  (7)
Day 15 (N = 16) 10  (9)
Day 29 (N = 11) 9  (11)
Day 43 (N = 8) 10  (10)
End of Infusion (N = 9) 8  (9)
End of Core Study (N = 6) 9  (13)
3-Month Follow-up (N = 5) 4  (3)
6-Month Follow-up (N = 6) 4  (7)
9-Month Follow-up (N = 4) 11  (15)
12-Month Follow-up (N = 4) 12  (14)
15-Month Follow-up (N = 3) 10  (9)
18-Month Follow-up (N = 3) 19  (19)
21-Month Follow-up (N = 21) 23  (9)
24-Month Follow-up (N = 3) 8  (10)
27.Secondary Outcome
Title CD4+ Central Memory T-Cell (TCM) Count
Hide Description Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.048  (0.053)
Day 1 Prior (N = 24) 0.029  (0.034)
Day 8 (N = 21) 0.027  (0.042)
Day 15 (N = 16) 0.014  (0.025)
Day 29 (N = 11) 0.032  (0.065)
Day 43 (N = 8) 0.032  (0.035)
End of Infusion (N = 9) 0.049  (0.103)
End of Core Study (N = 6) 0.062  (0.075)
3-Month Follow-up (N = 5) 0.019  (0.009)
6-Month Follow-up (N = 6) 0.027  (0.020)
9-Month Follow-up (N = 4) 0.043  (0.056)
12-Month Follow-up (N = 4) 0.065  (0.073)
15-Month Follow-up (N = 3) 0.039  (0.020)
18-Month Follow-up (N = 3) 0.033  (0.031)
21-Month Follow-up (N = 21) 0.056  (0.054)
24-Month Follow-up (N = 3) 0.021  (0.010)
28.Secondary Outcome
Title CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Hide Description Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD4+ T-cells
Screening (N = 25) 18  (12)
Day 1 Prior (N = 24) 20  (15)
Day 8 (N = 21) 19  (15)
Day 15 (N = 16) 14  (12)
Day 29 (N = 11) 13  (10)
Day 43 (N = 8) 13  (9)
End of Infusion (N = 9) 15  (11)
End of Core Study (N = 6) 14  (11)
3-Month Follow-up (N = 5) 6  (3)
6-Month Follow-up (N = 6) 9  (4)
9-Month Follow-up (N = 4) 11  (9)
12-Month Follow-up (N = 4) 18  (16)
15-Month Follow-up (N = 3) 13  (6)
18-Month Follow-up (N = 3) 18  (14)
21-Month Follow-up (N = 21) 14  (4)
24-Month Follow-up (N = 3) 12  (11)
29.Secondary Outcome
Title CD4+ Effector Memory T-Cell (TEM) Count
Hide Description Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.161  (0.089)
Day 1 Prior (N = 24) 0.099  (0.096)
Day 8 (N = 21) 0.083  (0.076)
Day 15 (N = 16) 0.051  (0.044)
Day 29 (N = 11) 0.097  (0.059)
Day 43 (N = 8) 0.169  (0.117)
End of Infusion (N = 9) 0.140  (0.091)
End of Core Study (N = 6) 0.220  (0.142)
3-Month Follow-up (N = 5) 0.279  (0.153)
6-Month Follow-up (N = 6) 0.267  (0.158)
9-Month Follow-up (N = 4) 0.191  (0.037)
12-Month Follow-up (N = 4) 0.226  (0.100)
15-Month Follow-up (N = 3) 0.199  (0.087)
18-Month Follow-up (N = 3) 0.106  (0.066)
21-Month Follow-up (N = 21) 0.181  (0.107)
24-Month Follow-up (N = 3) 0.175  (0.133)
30.Secondary Outcome
Title CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Hide Description Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD4+ T-cells
Screening (N = 25) 41  (19)
Day 1 Prior (N = 24) 39  (19)
Day 8 (N = 21) 36  (19)
Day 15 (N = 16) 46  (17)
Day 29 (N = 11) 34  (20)
Day 43 (N = 8) 39  (26)
End of Infusion (N = 9) 41  (24)
End of Core Study (N = 6) 41  (24)
3-Month Follow-up (N = 5) 46  (26)
6-Month Follow-up (N = 6) 41  (21)
9-Month Follow-up (N = 4) 42  (18)
12-Month Follow-up (N = 4) 40  (15)
15-Month Follow-up (N = 3) 46  (17)
18-Month Follow-up (N = 3) 43  (12)
21-Month Follow-up (N = 21) 45  (3)
24-Month Follow-up (N = 3) 51  (22)
31.Secondary Outcome
Title CD8+ Naive T-Cell Count
Hide Description CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.029  (0.043)
Day 1 Prior (N = 24) 0.024  (0.050)
Day 8 (N = 21) 0.010  (0.012)
Day 15 (N = 16) 0.006  (0.005)
Day 29 (N = 11) 0.012  (0.014)
Day 43 (N = 8) 0.019  (0.036)
End of Infusion (N = 9) 0.011  (0.015)
End of Core Study (N = 6) 0.023  (0.018)
3-Month Follow-up (N = 5) 0.011  (0.007)
6-Month Follow-up (N = 6) 0.020  (0.022)
9-Month Follow-up (N = 4) 0.011  (0.012)
12-Month Follow-up (N = 4) 0.011  (0.009)
15-Month Follow-up (N = 3) 0.014  (0.011)
18-Month Follow-up (N = 3) 0.007  (0.008)
21-Month Follow-up (N = 21) 0.015  (0.006)
24-Month Follow-up (N = 3) 0.010  (0.009)
32.Secondary Outcome
Title CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Hide Description CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD8+ T-cells
Screening (N = 25) 10  (10)
Day 1 Prior (N = 24) 12  (13)
Day 8 (N = 21) 9  (8)
Day 15 (N = 16) 8  (7)
Day 29 (N = 11) 8  (7)
Day 43 (N = 8) 6  (7)
End of Infusion (N = 9) 3  (3)
End of Core Study (N = 6) 6  (6)
3-Month Follow-up (N = 5) 4  (4)
6-Month Follow-up (N = 6) 5  (5)
9-Month Follow-up (N = 4) 6  (7)
12-Month Follow-up (N = 4) 6  (6)
15-Month Follow-up (N = 3) 6  (5)
18-Month Follow-up (N = 3) 10  (8)
21-Month Follow-up (N = 21) 8  (4)
24-Month Follow-up (N = 3) 10  (12)
33.Secondary Outcome
Title CD8+ TCM Cell Counts
Hide Description Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 100 cells/µL
Screening (N = 25) 0.020  (0.027)
Day 1 Prior (N = 24) 0.014  (0.021)
Day 8 (N = 21) 0.010  (0.013)
Day 15 (N = 16) 0.004  (0.005)
Day 29 (N = 11) 0.007  (0.007)
Day 43 (N = 8) 0.012  (0.015)
End of Infusion (N = 9) 0.009  (0.009)
End of Core Study (N = 6) 0.016  (0.023)
3-Month Follow-up (N = 5) 0.008  (0.003)
6-Month Follow-up (N = 6) 0.016  (0.014)
9-Month Follow-up (N = 4) 0.006  (0.004)
12-Month Follow-up (N = 4) 0.010  (0.010)
15-Month Follow-up (N = 3) 0.004  (0.002)
18-Month Follow-up (N = 3) 0.002  (0.001)
21-Month Follow-up (N = 21) 0.002  (0.001)
24-Month Follow-up (N = 3) 0.006  (0.004)
34.Secondary Outcome
Title CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Hide Description Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD8+ T-cells
Screening (N = 25) 7  (7)
Day 1 Prior (N = 24) 8  (11)
Day 8 (N = 21) 10  (13)
Day 15 (N = 16) 4  (5)
Day 29 (N = 11) 7  (10)
Day 43 (N = 8) 9  (18)
End of Infusion (N = 9) 5  (6)
End of Core Study (N = 6) 5  (8)
3-Month Follow-up (N = 5) 3  (2)
6-Month Follow-up (N = 6) 4  (3)
9-Month Follow-up (N = 4) 3  (2)
12-Month Follow-up (N = 4) 3  (3)
15-Month Follow-up (N = 3) 2  (1)
18-Month Follow-up (N = 3) 2  (1)
21-Month Follow-up (N = 21) 1  (0)
24-Month Follow-up (N = 3) 6  (8)
35.Secondary Outcome
Title CD8+ Effector Memory T-Cell (TEM) Count
Hide Description Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.127  (0.162)
Day 1 Prior (N = 24) 0.075  (0.066)
Day 8 (N = 21) 0.065  (0.058)
Day 15 (N = 16) 0.045  (0.053)
Day 29 (N = 11) 0.067  (0.039)
Day 43 (N = 8) 0.135  (0.108)
End of Infusion (N = 9) 0.128  (0.077)
End of Core Study (N = 6) 0.180  (0.089)
3-Month Follow-up (N = 5) 0.146  (0.071)
6-Month Follow-up (N = 6) 0.179  (0.158)
9-Month Follow-up (N = 4) 0.116  (0.061)
12-Month Follow-up (N = 4) 0.174  (0.162)
15-Month Follow-up (N = 3) 0.095  (0.025)
18-Month Follow-up (N = 3) 0.049  (0.027)
21-Month Follow-up (N = 21) 0.085  (0.013)
24-Month Follow-up (N = 3) 0.054  (0.027)
36.Secondary Outcome
Title CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Hide Description Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD8+ T-cells
Screening (N = 25) 42  (19)
Day 1 Prior (N = 24) 42  (17)
Day 8 (N = 21) 46  (18)
Day 15 (N = 16) 43  (13)
Day 29 (N = 11) 51  (19)
Day 43 (N = 8) 46  (23)
End of Infusion (N = 9) 51  (21)
End of Core Study (N = 6) 49  (22)
3-Month Follow-up (N = 5) 47  (23)
6-Month Follow-up (N = 6) 50  (24)
9-Month Follow-up (N = 4) 50  (21)
12-Month Follow-up (N = 4) 51  (13)
15-Month Follow-up (N = 3) 46  (15)
18-Month Follow-up (N = 3) 46  (7)
21-Month Follow-up (N = 21) 46  (1)
24-Month Follow-up (N = 3) 33  (9)
37.Secondary Outcome
Title CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Hide Description Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: 1000 cells/µL
Screening (N = 25) 0.123  (0.099)
Day 1 Prior (N = 24) 0.072  (0.069)
Day 8 (N = 21) 0.051  (0.042)
Day 15 (N = 16) 0.047  (0.048)
Day 29 (N = 11) 0.058  (0.050)
Day 43 (N = 8) 0.132  (0.126)
End of Infusion (N = 9) 0.135  (0.131)
End of Core Study (N = 6) 0.226  (0.249)
3-Month Follow-up (N = 5) 0.214  (0.220)
6-Month Follow-up (N = 6) 0.187  (0.182)
9-Month Follow-up (N = 4) 0.094  (0.046)
12-Month Follow-up (N = 4) 0.117  (0.065)
15-Month Follow-up (N = 3) 0.099  (0.041)
18-Month Follow-up (N = 3) 0.047  (0.035)
21-Month Follow-up (N = 21) 0.086  (0.016)
24-Month Follow-up (N = 3) 0.100  (0.084)
38.Secondary Outcome
Title CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Hide Description Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.
Time Frame Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Arm/Group Title Blinatumomab
Hide Arm/Group Description:
All participants who received blinatumomab by continuous intravenous infusion during the core study.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage of CD8+ T-cells
Screening (N = 25) 41  (19)
Day 1 Prior (N = 24) 39  (19)
Day 8 (N = 21) 36  (19)
Day 15 (N = 16) 46  (17)
Day 29 (N = 11) 34  (20)
Day 43 (N = 8) 39  (26)
End of Infusion (N = 9) 41  (24)
End of Core Study (N = 6) 41  (24)
3-Month Follow-up (N = 5) 46  (26)
6-Month Follow-up (N = 6) 41  (21)
9-Month Follow-up (N = 4) 42  (18)
12-Month Follow-up (N = 4) 40  (15)
15-Month Follow-up (N = 3) 46  (17)
18-Month Follow-up (N = 3) 43  (12)
21-Month Follow-up (N = 21) 45  (3)
24-Month Follow-up (N = 3) 51  (22)
Time Frame From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Event Reporting Description

Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d Cohort 1+3: Blinatumomab 9/28/112µg/d Blinatumomab Overall
Hide Arm/Group Description Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval. All participants who received blinatumomab by continuous intravenous infusion during the core study.
All-Cause Mortality
Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d Cohort 1+3: Blinatumomab 9/28/112µg/d Blinatumomab Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d Cohort 1+3: Blinatumomab 9/28/112µg/d Blinatumomab Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   2/2 (100.00%)   12/14 (85.71%)   21/23 (91.30%)   23/25 (92.00%) 
Blood and lymphatic system disorders           
Agranulocytosis † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Bone marrow toxicity † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Neutropenia † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Cardiac disorders           
Supraventricular tachycardia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Endocrine disorders           
Adrenal insufficiency † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Gastrointestinal disorders           
Oesophagitis † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
General disorders           
Disease progression † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Pain † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pyrexia † 1  1/9 (11.11%)  1/2 (50.00%)  2/14 (14.29%)  3/23 (13.04%)  4/25 (16.00%) 
Infections and infestations           
Catheter site infection † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Device related infection † 1  0/9 (0.00%)  0/2 (0.00%)  5/14 (35.71%)  5/23 (21.74%)  5/25 (20.00%) 
Herpes virus infection † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Lobar pneumonia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Lung infection † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Pneumonia † 1  3/9 (33.33%)  1/2 (50.00%)  2/14 (14.29%)  5/23 (21.74%)  6/25 (24.00%) 
Viral infection † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Injury, poisoning and procedural complications           
Accidental overdose † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Drug administration error † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Infusion related reaction † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Investigations           
Pancreatic enzymes increased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Metabolism and nutrition disorders           
Dehydration † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Intervertebral disc protrusion † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Nervous system disorders           
Aphasia † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Convulsion † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Dizziness † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Encephalopathy † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Epilepsy † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Neurological symptom † 1  1/9 (11.11%)  1/2 (50.00%)  0/14 (0.00%)  1/23 (4.35%)  2/25 (8.00%) 
Speech disorder † 1  1/9 (11.11%)  1/2 (50.00%)  0/14 (0.00%)  1/23 (4.35%)  2/25 (8.00%) 
Syncope † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Tremor † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders           
Pleurisy † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pulmonary embolism † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Respiratory failure † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Vascular disorders           
Deep vein thrombosis † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Blinatumomab 9/28/112 µg/d Cohort 2: Blinatumomab 112 µg/d Cohort 3: Blinatumomab 9/28/112 µg/d Cohort 1+3: Blinatumomab 9/28/112µg/d Blinatumomab Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   2/2 (100.00%)   14/14 (100.00%)   23/23 (100.00%)   25/25 (100.00%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/9 (0.00%)  1/2 (50.00%)  1/14 (7.14%)  1/23 (4.35%)  2/25 (8.00%) 
Leukopenia † 1  1/9 (11.11%)  0/2 (0.00%)  3/14 (21.43%)  4/23 (17.39%)  4/25 (16.00%) 
Neutropenia † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Thrombocytopenia † 1  1/9 (11.11%)  0/2 (0.00%)  4/14 (28.57%)  5/23 (21.74%)  5/25 (20.00%) 
Cardiac disorders           
Arrhythmia † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Cardiac failure † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Cardiovascular insufficiency † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Tachycardia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Ear and labyrinth disorders           
Deafness † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Vertigo † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Eye disorders           
Blepharospasm † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Keratitis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Visual acuity reduced † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Gastrointestinal disorders           
Abdominal discomfort † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Abdominal pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Aphthous stomatitis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Constipation † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Diarrhoea † 1  4/9 (44.44%)  1/2 (50.00%)  1/14 (7.14%)  5/23 (21.74%)  6/25 (24.00%) 
Dyspepsia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Flatulence † 1  0/9 (0.00%)  0/2 (0.00%)  2/14 (14.29%)  2/23 (8.70%)  2/25 (8.00%) 
Gastrointestinal motility disorder † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Mouth ulceration † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Nausea † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Odynophagia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Vomiting † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
General disorders           
Asthenia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Catheter site erythema † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Catheter site rash † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Chills † 1  1/9 (11.11%)  0/2 (0.00%)  2/14 (14.29%)  3/23 (13.04%)  3/25 (12.00%) 
Disease progression † 1  0/9 (0.00%)  0/2 (0.00%)  3/14 (21.43%)  3/23 (13.04%)  3/25 (12.00%) 
Facial pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Fatigue † 1  3/9 (33.33%)  1/2 (50.00%)  3/14 (21.43%)  6/23 (26.09%)  7/25 (28.00%) 
General physical health deterioration † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Mucosal inflammation † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Oedema † 1  1/9 (11.11%)  0/2 (0.00%)  5/14 (35.71%)  6/23 (26.09%)  6/25 (24.00%) 
Oedema peripheral † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Pyrexia † 1  4/9 (44.44%)  1/2 (50.00%)  5/14 (35.71%)  9/23 (39.13%)  10/25 (40.00%) 
Ulcer † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Hepatobiliary disorders           
Jaundice † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Immune system disorders           
Drug hypersensitivity † 1  1/9 (11.11%)  1/2 (50.00%)  0/14 (0.00%)  1/23 (4.35%)  2/25 (8.00%) 
Infections and infestations           
Bronchitis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Candida infection † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Candiduria † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Conjunctivitis † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Diverticulitis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Fungal infection † 1  1/9 (11.11%)  1/2 (50.00%)  0/14 (0.00%)  1/23 (4.35%)  2/25 (8.00%) 
Herpes simplex † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Infection † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Nasopharyngitis † 1  0/9 (0.00%)  0/2 (0.00%)  3/14 (21.43%)  3/23 (13.04%)  3/25 (12.00%) 
Otitis media † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pneumonia † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Respiratory tract infection † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Rhinitis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Urinary tract infection † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Vulvovaginal candidiasis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Injury, poisoning and procedural complications           
Spinal compression fracture † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Investigations           
Antithrombin III decreased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Blood fibrinogen increased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Blood glucose increased † 1  0/9 (0.00%)  0/2 (0.00%)  4/14 (28.57%)  4/23 (17.39%)  4/25 (16.00%) 
Blood immunoglobulin G decreased † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Blood lactate dehydrogenase increased † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Blood magnesium decreased † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Blood potassium decreased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Blood sodium decreased † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Blood uric acid increased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
C-reactive protein increased † 1  1/9 (11.11%)  0/2 (0.00%)  3/14 (21.43%)  4/23 (17.39%)  4/25 (16.00%) 
Corneal reflex decreased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Fibrin D dimer increased † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Fibrinolysis increased † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Gamma-glutamyltransferase increased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Hepatic enzyme increased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Neutrophil count decreased † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
PO2 decreased † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Platelet count decreased † 1  0/9 (0.00%)  1/2 (50.00%)  1/14 (7.14%)  1/23 (4.35%)  2/25 (8.00%) 
Weight increased † 1  0/9 (0.00%)  0/2 (0.00%)  3/14 (21.43%)  3/23 (13.04%)  3/25 (12.00%) 
White blood cell count decreased † 1  0/9 (0.00%)  1/2 (50.00%)  1/14 (7.14%)  1/23 (4.35%)  2/25 (8.00%) 
Metabolism and nutrition disorders           
Diabetes mellitus † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Hyperglycaemia † 1  2/9 (22.22%)  1/2 (50.00%)  2/14 (14.29%)  4/23 (17.39%)  5/25 (20.00%) 
Hypocalcaemia † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Hypokalaemia † 1  1/9 (11.11%)  0/2 (0.00%)  3/14 (21.43%)  4/23 (17.39%)  4/25 (16.00%) 
Vitamin K deficiency † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  1/9 (11.11%)  0/2 (0.00%)  2/14 (14.29%)  3/23 (13.04%)  3/25 (12.00%) 
Bone pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Intervertebral disc protrusion † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Muscular weakness † 1  2/9 (22.22%)  1/2 (50.00%)  0/14 (0.00%)  2/23 (8.70%)  3/25 (12.00%) 
Musculoskeletal pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Myopathy † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Neck pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Pain in extremity † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasm progression † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Oncologic complication † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Tumour pain † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Nervous system disorders           
Ataxia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Burning sensation † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Coordination abnormal † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Dizziness † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Dyscalculia † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Dysgeusia † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Encephalopathy † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Epilepsy † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Facial paresis † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Headache † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Hyporeflexia † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Memory impairment † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Paraesthesia † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Radiculopathy † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Sensory disturbance † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Somnolence † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Speech disorder † 1  3/9 (33.33%)  1/2 (50.00%)  0/14 (0.00%)  3/23 (13.04%)  4/25 (16.00%) 
Tremor † 1  6/9 (66.67%)  2/2 (100.00%)  4/14 (28.57%)  10/23 (43.48%)  12/25 (48.00%) 
Vocal cord paralysis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Psychiatric disorders           
Confusional state † 1  1/9 (11.11%)  0/2 (0.00%)  1/14 (7.14%)  2/23 (8.70%)  2/25 (8.00%) 
Disorientation † 1  2/9 (22.22%)  1/2 (50.00%)  0/14 (0.00%)  2/23 (8.70%)  3/25 (12.00%) 
Encopresis † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Fear † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Insomnia † 1  0/9 (0.00%)  0/2 (0.00%)  2/14 (14.29%)  2/23 (8.70%)  2/25 (8.00%) 
Nervousness † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Sleep disorder † 1  0/9 (0.00%)  0/2 (0.00%)  2/14 (14.29%)  2/23 (8.70%)  2/25 (8.00%) 
Renal and urinary disorders           
Enuresis † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Haematuria † 1  2/9 (22.22%)  0/2 (0.00%)  0/14 (0.00%)  2/23 (8.70%)  2/25 (8.00%) 
Renal failure † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Ureteric obstruction † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Urinary retention † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough † 1  3/9 (33.33%)  1/2 (50.00%)  1/14 (7.14%)  4/23 (17.39%)  5/25 (20.00%) 
Dysphonia † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Dyspnoea † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Nasal disorder † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pleural effusion † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pulmonary congestion † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Pulmonary embolism † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Rhinorrhoea † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Tachypnoea † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis allergic † 1  0/9 (0.00%)  1/2 (50.00%)  0/14 (0.00%)  0/23 (0.00%)  1/25 (4.00%) 
Drug eruption † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Eczema asteatotic † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Hyperhidrosis † 1  1/9 (11.11%)  0/2 (0.00%)  2/14 (14.29%)  3/23 (13.04%)  3/25 (12.00%) 
Night sweats † 1  1/9 (11.11%)  0/2 (0.00%)  2/14 (14.29%)  3/23 (13.04%)  3/25 (12.00%) 
Rash † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Skin ulcer † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
Vascular disorders           
Embolism † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Haematoma † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Hypotension † 1  1/9 (11.11%)  0/2 (0.00%)  0/14 (0.00%)  1/23 (4.35%)  1/25 (4.00%) 
Thrombosis † 1  0/9 (0.00%)  0/2 (0.00%)  1/14 (7.14%)  1/23 (4.35%)  1/25 (4.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen, Inc.
Phone: 866-572-6436
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT01741792    
Other Study ID Numbers: MT103-208
2011-005781-38 ( EudraCT Number )
First Submitted: November 28, 2012
First Posted: December 5, 2012
Results First Submitted: June 26, 2015
Results First Posted: July 27, 2015
Last Update Posted: January 6, 2017