A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Part of paid clinical trials in Huntsville, Alabama.
- Sponsor
- Gilead Sciences
- Study ID
- NCT01539512
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Idelalisib — DRUGIdelalisib 150 mg tablet administered orally twice daily
- Rituximab — DRUGRituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
- Placebo to match idelalisib — DRUGPlacebo to match idelalisib administered orally twice daily
Study Details
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Key Dates
- Start date
- Apr 30, 2012
- Status verified
- Apr 2015
- Primary completion
- Oct 31, 2013
- Completion
- Apr 30, 2014
Study Design
- Enrollment
- 220 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Idelalisib + rituximabParticipants will receive idelalisib plus rituximab
- Placebo Comparator: Placebo + rituximabParticipants will receive placebo to match idelalisib plus rituximab
Primary Outcome Measure
Progression-Free Survival [ Time Frame: Up to 17 months ]
Locations (34)
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