Trials / Terminated
TerminatedNCT02538614
Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
A Phase 1b/2 Study of Idelalisib in Combination With BI 836826 in Subjects With Chronic Lymphocytic Leukemia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idelalisib | Tablets administered orally twice daily |
| DRUG | BI 836826 | Intravenous administration as a rate-controlled infusion |
Timeline
- Start date
- 2015-12-29
- Primary completion
- 2017-07-05
- Completion
- 2017-07-05
- First posted
- 2015-09-02
- Last updated
- 2020-11-25
- Results posted
- 2020-11-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02538614. Inclusion in this directory is not an endorsement.