Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
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ClinicalTrials.gov Identifier: NCT02393859 |
Recruitment Status :
Completed
First Posted : March 20, 2015
Results First Posted : July 13, 2020
Last Update Posted : February 21, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Leukemia, Acute Lymphoblastic |
Interventions |
Drug: Blinatumomab Drug: Dexamethasone Drug: Vincrisitne Drug: Daunorubicin Drug: Methotrexate Drug: Ifosfamide Drug: PEG-asparaginase Drug: Erwinia-asparaginase |
Enrollment | 111 |
Participant Flow
Recruitment Details |
This study was conducted at 48 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015. The last participant enrolled on 30 August 2019. The primary completion date was 17 July 2019 and the study completion date was 21 November 2022. |
Pre-assignment Details |
After a 3-week screening period, participants were enrolled and randomized 1:1 into 1 of 2 treatment groups: High Risk Consolidation 3 (HC3) chemotherapy or blinatumomab. Randomization was stratified by age and bone marrow/minimal residual disease (MRD) status. |
Arm/Group Title | HC3 Chemotherapy | Blinatumomab |
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Arm/Group Description | One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day intravenous [IV] on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or intramuscularly [IM] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses). | One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI). |
Period Title: Overall Study | ||
Started | 57 | 54 |
Participants Treated | 52 | 54 |
Participants in the Primary Analysis Population [1] | 54 | 54 |
Participants in the Final Analysis Population [2] | 57 | 54 |
Completed | 16 | 33 |
Not Completed | 41 | 21 |
Reason Not Completed | ||
Decision by Sponsor | 2 | 4 |
Withdrawal by Subject | 11 | 6 |
Death | 27 | 10 |
Lost to Follow-up | 1 | 1 |
[1]
Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (the full analysis set; FAS) at the primary completion date (17 July 2019)
[2]
Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (FAS) at study completion (21 November 2022)
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Baseline Characteristics
Arm/Group Title | HC3 Chemotherapy | Blinatumomab | Total | |
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Arm/Group Description | One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses). | One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI). | Total of all reporting groups | |
Overall Number of Baseline Participants | 57 | 54 | 111 | |
Baseline Analysis Population Description |
The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 57 participants | 54 participants | 111 participants | |
6.6 (4.3) | 7.3 (4.4) | 7.0 (4.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 54 participants | 111 participants | |
Female |
34 59.6%
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24 44.4%
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58 52.3%
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Male |
23 40.4%
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30 55.6%
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53 47.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 54 participants | 111 participants | |
Hispanic or Latino |
3 5.3%
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1 1.9%
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4 3.6%
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Not Hispanic or Latino |
54 94.7%
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53 98.1%
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107 96.4%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 54 participants | 111 participants | |
White |
46 80.7%
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50 92.6%
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96 86.5%
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Other, Not Specified |
5 8.8%
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3 5.6%
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8 7.2%
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Asian |
3 5.3%
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1 1.9%
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4 3.6%
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Black or African American |
3 5.3%
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0 0.0%
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3 2.7%
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Stratification Factor: Age Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 54 participants | 111 participants | |
1 to 9 years |
41 71.9%
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39 72.2%
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80 72.1%
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Other (< 1 year and > 9 years) |
16 28.1%
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15 27.8%
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31 27.9%
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Stratification Factor: Marrow/Minimal Residual Disease (MRD)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 57 participants | 54 participants | 111 participants |
M1 Marrow + MRD level ≥ 10^-3 | 17 | 15 | 32 | |
M1 Marrow + MRD level < 10^-3 | 36 | 35 | 71 | |
M2 Marrow | 4 | 4 | 8 | |
[1]
Measure Description: M1: representative bone marrow aspirate or biopsy with blasts < 5%, with satisfactory cellularity and with regenerating hematopoiesis; M2: representative bone marrow aspirate or biopsy with ≥ 5% and < 25% blasts; MRD=minimal residual disease levels ≥ 10^-3 or < 10^-3, by polymerase chain reaction (PCR) or flow cytometry.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Study Director |
Organization: | Amgen Inc. |
Phone: | 866-572-6436 |
EMail: | medinfo@amgen.com |
Publications:
Blinatumomabe em pacientes pediátricos com leucemia linfoblástica aguda B em primeira recidiva de alto risco: um estudo de custo-efetividade. van Beurden-Tan CHY, Ribeiro RA, Seber A, de Martino Lee ML, Marçola M, Schuetz R, Loggetto SR, Maiolino A. Jornal Brasileiro de Economia da Saúde 14(1): 41-50. 10.21115/JBES.v14.n1.p41-50
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT02393859 |
Other Study ID Numbers: |
20120215 2014-002476-92 ( EudraCT Number ) |
First Submitted: | March 16, 2015 |
First Posted: | March 20, 2015 |
Results First Submitted: | June 24, 2020 |
Results First Posted: | July 13, 2020 |
Last Update Posted: | February 21, 2024 |