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NCT02910583 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
A Phase 2 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT02910583: Completed Phase 2 study, sponsored by Pharmacyclics.
NCT02910583 is a Phase 2 study that has completed, run by Pharmacyclics. The registered enrollment target is 323 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02910583, a Phase 2 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
Primary Outcome
DFS is defined as time from randomization date to MRD-positive relapse, or disease progression per investigator assessment (per 2008 International Workshop for Chronic Lymphocytic Leukemia \[IWCLL\] criteria \[Halleck et al\]) or death from any cause, whichever occurred first. 1-year DFS estimated using Kaplan-Meier method at 12 months landmark time.
Interventions
- DRUG Placebo
- DRUG venetoclax
- DRUG ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2016-09-28 |
| Est. Completion | 2024-03-27 |
| Phase | Phase 2 |
What the finished NCT02910583 record still lists
NCT02910583 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02910583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02910583 about?
NCT02910583 is a clinical study titled "Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)". This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
What is the current status of trial NCT02910583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2016-09-28. Estimated completion is 2024-03-27.
What interventions are being tested in trial NCT02910583?
The interventions under investigation include: Placebo (DRUG), venetoclax (DRUG), ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02910583?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02910583's enrollment target sits among peer trials
323 150th of 2000 higher than 1,851 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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