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NCT03053440 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
A Phase 3 study, sponsored by BeiGene.
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT03053440: Completed Phase 3 study, sponsored by BeiGene.
NCT03053440 is a Phase 3 study that has completed, run by BeiGene. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03053440, a Phase 3 study, has completed, sponsored by BeiGene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
Primary Outcome
Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
Interventions
- DRUG Ibrutinib
- DRUG BGB-3111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2017-01-25 |
| Est. Completion | 2022-06-21 |
| Phase | Phase 3 |
What the finished NCT03053440 record still lists
NCT03053440 is an interventional study that assigns participants to a tested intervention. The registered 201 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT03053440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03053440 about?
NCT03053440 is a clinical study titled "A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)". This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
What is the current status of trial NCT03053440?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2017-01-25. Estimated completion is 2022-06-21.
What interventions are being tested in trial NCT03053440?
The interventions under investigation include: Ibrutinib (DRUG), BGB-3111 (DRUG).
Who is sponsoring clinical trial NCT03053440?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03053440's enrollment target sits among peer trials
201 1353rd of 2000 higher than 648 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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