Trial Outcomes & Findings for Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma (NCT NCT00904722)
NCT ID: NCT00904722
Last Updated: 2016-06-03
Results Overview
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.
COMPLETED
PHASE2
32 participants
Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.
2016-06-03
Participant Flow
Recruitment Period: January 08, 2010 to January 05, 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Thirty-two patients were enrolled, out of which two patients were ineligible and not treated.
Participant milestones
| Measure |
Pidilizumab (CT-011)
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 Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pidilizumab (CT-011)
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).
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|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Pidilizumab (CT-011)
n=30 Participants
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).
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|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.Population: One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.
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.
Outcome measures
| Measure |
Pidilizumab (CT-011)
n=29 Participants
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).
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|---|---|
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Overall Response Rate
Complete Response
|
15 participants
|
|
Overall Response Rate
Partial Response
|
4 participants
|
SECONDARY outcome
Timeframe: Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.Population: One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.
Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.
Outcome measures
| Measure |
Pidilizumab (CT-011)
n=29 Participants
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).
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|---|---|
|
Progression-Free Survival
|
18.8 months
Interval 14.7 to
Distributional assumptions were not available making it not possible to obtain an exact 95% confidence interval for the median.
|
Adverse Events
Pidilizumab (CT-011)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pidilizumab (CT-011)
n=30 participants at risk
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).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
46.7%
14/30 • Number of events 14 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
General disorders
Fatigue
|
50.0%
15/30 • Number of events 15 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Blood and lymphatic system disorders
Leucopenia
|
36.7%
11/30 • Number of events 11 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
10/30 • Number of events 10 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • Number of events 6 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
6/30 • Number of events 6 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Number of events 5 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
General disorders
Sweating
|
13.3%
4/30 • Number of events 4 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Nervous system disorders
Neuropathy
|
13.3%
4/30 • Number of events 4 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Number of events 4 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
General disorders
Pain
|
16.7%
5/30 • Number of events 5 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Blood and lymphatic system disorders
Oedema
|
13.3%
4/30 • Number of events 4 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
3/30 • Number of events 3 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 3 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Gastrointestinal disorders
Anorexia
|
10.0%
3/30 • Number of events 3 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Cardiac disorders
Hypotension
|
10.0%
3/30 • Number of events 3 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
20.0%
6/30 • Number of events 6 • Adverse events were captured from Day 1 to 30 days from the last treatment by study drug.
|
Additional Information
Sattva S. Neelapu, MD/Associate Professor, Lymphoma/Myeloma
The University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place