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Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT00904722
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
CureTech Ltd
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: CT-011
Drug: Rituximab
Enrollment 32
Recruitment Details Recruitment Period: January 08, 2010 to January 05, 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Thirty-two patients were enrolled, out of which two patients were ineligible and not treated.
Arm/Group Title Pidilizumab (CT-011)
Hide Arm/Group Description Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Pidilizumab (CT-011)
Hide Arm/Group Description Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
61
(35 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Overall Response Rate
Hide Description Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.
Time Frame Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.
Arm/Group Title Pidilizumab (CT-011)
Hide Arm/Group Description:
Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Complete Response 15
Partial Response 4
2.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.
Time Frame Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.
Arm/Group Title Pidilizumab (CT-011)
Hide Arm/Group Description:
Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
18.8 [1] 
(14.7 to NA)
[1]
Distributional assumptions were not available making it not possible to obtain an exact 95% confidence interval for the median.
Time Frame Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pidilizumab (CT-011)
Hide Arm/Group Description Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
All-Cause Mortality
Pidilizumab (CT-011)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pidilizumab (CT-011)
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pidilizumab (CT-011)
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Anaemia † 1  14/30 (46.67%)  14
Leucopenia † 1  11/30 (36.67%)  11
Thrombocytopenia † 1  10/30 (33.33%)  10
Neutropenia † 1  6/30 (20.00%)  6
Oedema † 1  4/30 (13.33%)  4
Cardiac disorders   
Hypotension † 1  3/30 (10.00%)  3
Gastrointestinal disorders   
Nausea † 1  5/30 (16.67%)  5
Diarrhea † 1  3/30 (10.00%)  3
Anorexia † 1  3/30 (10.00%)  3
General disorders   
Fatigue † 1  15/30 (50.00%)  15
Sweating † 1  4/30 (13.33%)  4
Pain † 1  5/30 (16.67%)  5
Nervous system disorders   
Neuropathy † 1  4/30 (13.33%)  4
Respiratory, thoracic and mediastinal disorders   
Dyspnea † 1  6/30 (20.00%)  6
Cough † 1  4/30 (13.33%)  4
Respiratory Infection † 1  6/30 (20.00%)  6
Skin and subcutaneous tissue disorders   
Pruritus † 1  3/30 (10.00%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sattva S. Neelapu, MD/Associate Professor, Lymphoma/Myeloma
Organization: The University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00904722    
Other Study ID Numbers: 2009-0163
NCI-2011-03225 ( Registry Identifier: NCI CTRP )
First Submitted: May 18, 2009
First Posted: May 20, 2009
Results First Submitted: April 27, 2016
Results First Posted: June 3, 2016
Last Update Posted: June 3, 2016