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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 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02538614
The ClinicalTrials.gov registry entry for NCT02538614 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Idelalisib is the first listed.
NCT02538614 reports 0 study locations.
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.
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