A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Overview
- Phase
- Phase 3
- Intervention
- Idelalisib
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Gilead Sciences
- Enrollment
- 416
- Locations
- 104
- Primary Endpoint
- Progression-Free Survival (PFS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Previously treated recurrent CLL
- •Measurable lymphadenopathy
- •Requires therapy for CLL
- •Has experienced CLL progression \< 36 months since the completion of the last prior therapy
Exclusion Criteria
- •Recent history of a major non-CLL malignancy
- •Evidence of an ongoing infection
- •CLL refractory to bendamustine
- •Concurrent participation in another therapeutic clinical trial
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Arms & Interventions
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
Intervention: Idelalisib
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
Intervention: Rituximab
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
Intervention: Bendamustine
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Intervention: Rituximab
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Intervention: Bendamustine
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Intervention: Placebo to match idelalisib
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: Up to 84 months
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Secondary Outcomes
- Complete Response Rate(Up to 84 months)
- Overall Response Rate (ORR)(Up to 84 months)
- Lymph Node Response Rate(Up to 84 months)
- Overall Survival(Up to 84 months)