Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
Stopped early · Phase 1
Conditions studied: Chronic Lymphocytic Leukemia (CLL)
In brief
This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI 836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and establish the high recommended Phase 2 combination dose (highRP2D) as well as an alternate lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of complete response (CR) and of minimal residual disease (MRD) negativity with the combination at the highRP2D and the lowRP2D in participants with R/R CLL.
Key facts
- Study ID
- NCT02538614
- Run by
- Gilead Sciences
- People needed
- 2
- Starts
- 2015-12-29
- Expected to finish
- 2017-07-05
- Last updated by the study team
- 2020-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ohio State University — Columbus, Ohio, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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