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NCT02956382 · ClinicalTrials.gov registry record · Phase 1
Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02956382: Completed Phase 1 study, sponsored by Georgetown University.
NCT02956382 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02956382, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.
Primary Outcome
The maximum tolerated dose of Ibrutinib and Venetoclax as determined by number of DLTs observed. • If 0/3 DLT is observed, dose escalation will continue to the next upper dose level. • If ≥ 2/3 DLTs are observed, then the dose finding procedure will be terminated. • If 1/3 DLT is observed, then 3 additional patients will be enrolled in the same dose level. If no DLT is observed from the additional 3 patients, then dose escalation will continue to the next upper dose level. If any DLT is observe
Interventions
- DRUG Venetoclax
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 1 |
What the finished NCT02956382 record still lists
NCT02956382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT02956382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02956382 about?
NCT02956382 is a clinical study titled "Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma". This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.
What is the current status of trial NCT02956382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-03-01. Estimated completion is 2024-03-07.
What interventions are being tested in trial NCT02956382?
The interventions under investigation include: Venetoclax (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02956382?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02956382's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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