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NCT02538614 · ClinicalTrials.gov registry record · Phase 1
Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02538614: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT02538614 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02538614, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
DLTs refer to toxicities experienced during the final 6 weeks of 7-week study treatment that have been judged to be clinically significant and related to study treatment. Events occurring during the initial 7-day idelalisib monotherapy run-in period and resolving by Day 8 were not included.
Interventions
- DRUG Idelalisib
- DRUG BI 836826
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-12-29 |
| Est. Completion | 2017-07-05 |
| Phase | Phase 1 |
Why NCT02538614 stopped before completion
NCT02538614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Idelalisib is the first listed.
NCT02538614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02538614 about?
NCT02538614 is a clinical study titled "Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia". 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 recommen...
What is the current status of trial NCT02538614?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-12-29. Estimated completion is 2017-07-05.
What interventions are being tested in trial NCT02538614?
The interventions under investigation include: Idelalisib (DRUG), BI 836826 (DRUG).
Who is sponsoring clinical trial NCT02538614?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02538614's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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