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NCT05952037 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
A Phase 2 study of Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent, sponsored by BeOne Medicines.
- Active
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 20
- Study locations
NCT05952037: Active Phase 2 study of Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent, sponsored by BeOne Medicines.
NCT05952037 is a Phase 2 study of Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent that is active but no longer recruiting, run by BeOne Medicines. The registered enrollment target is 114 participants, below the 470-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05952037, a Phase 2 study of Waldenstrom Macroglobulinemia and Waldenstrom's Macroglobulinemia Recurrent, is active but no longer recruiting, sponsored by BeOne Medicines.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Primary Outcome
MRR is defined as the percentage of participants achieving partial response (PR) or better, as assessed by the Independent Review Committee (IRC) per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM-11) WM response criteria.
Conditions Studied
Interventions
- DRUG Zanubrutinib
- DRUG Sonrotoclax
Study Locations (20)
New South Wales
- Concord Repatriation General Hospital - Concord
- Genesiscare North Shore - St Leonards
California
- City of Hope National Medical Center - Duarte
Colorado
- Colorado Blood Cancer Institute - Denver
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Florida
- University of Miami - Miami
Illinois
- Northwestern Medicine Cancer Center - Warrenville
Iowa
- Mission Cancer and Blood - Waukee
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What the registry record for NCT05952037 still lists
NCT05952037 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 470-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (76% lower).
The record links to 3 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 2 interventions - of which Zanubrutinib is the first listed.
NCT05952037 names 20 study sites across 19 states, led by New South Wales, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05952037 about?
NCT05952037 is a clinical study titled "A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia". This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
What is the current status of trial NCT05952037?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2023-10-23. Estimated completion is 2028-08.
What conditions does trial NCT05952037 study?
This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory.
What interventions are being tested in trial NCT05952037?
The interventions under investigation include: Zanubrutinib (DRUG), Sonrotoclax (DRUG).
Who is sponsoring clinical trial NCT05952037?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05952037 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Waldenstrom Macroglobulinemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05952037's enrollment target sits among peer trials
114 13th of 34 higher than 22 of 34 other Waldenstrom Macroglobulinemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Waldenstrom Macroglobulinemia 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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