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NCT02165397 · ClinicalTrials.gov registry record · Phase 3
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
A Phase 3 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 181
- Enrollment target
NCT02165397: Completed Phase 3 study, sponsored by Pharmacyclics.
NCT02165397 is a Phase 3 study that has completed, run by Pharmacyclics. The registered enrollment target is 181 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165397, a Phase 3 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 181 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).
Primary Outcome
PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network \[NCCN\] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time o
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2014-07-07 |
| Est. Completion | 2019-11-07 |
| Phase | Phase 3 |
What the finished NCT02165397 record still lists
NCT02165397 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02165397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02165397 about?
NCT02165397 is a clinical study titled "Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia". The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).
What is the current status of trial NCT02165397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 181 participants. The study started on 2014-07-07. Estimated completion is 2019-11-07.
What interventions are being tested in trial NCT02165397?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02165397?
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 NCT02165397's enrollment target sits among peer trials
181 1422nd of 2000 higher than 579 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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