drugset / Trial / NCT02538614
Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-12-29
- Primary completion
- 2017-07-05
- Completion
- 2017-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 836826 | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Idelalisib | Small molecule | 50 mg | Oral |
| Subject | Idelalisib | Small molecule | 100 mg | Oral |
| Subject | Idelalisib | Small molecule | 150 mg | Oral |