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NCT05976763 · ClinicalTrials.gov registry record · Phase 3
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
A Phase 3 study of Mantle Cell Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 421
- Enrollment target
- 20
- Study locations
NCT05976763: Recruiting Phase 3 study of Mantle Cell Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT05976763 is a Phase 3 study of Mantle Cell Lymphoma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 421 participants, above the 100-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (321% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05976763, a Phase 3 study of Mantle Cell Lymphoma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 421 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
Primary Outcome
Hazard ratios on the treatment effect will be estimated using a stratified cox proportional hazards model, stratified on age and mantle cell lymphoma (MCL) International Prognostic Index (IPI) score. The primary analysis for non-inferiority will be based on an intent-to-treat (ITT) analysis and will include all randomized patients in the analyses, regardless of eligibility or treatment status. Sensitivity analyses will also be done in an ancillary manner to evaluate and compare our endpoints usi
Conditions Studied
Interventions
- DRUG Zanubrutinib
- PROCEDURE Bone Marrow Biopsy
- OTHER Fludeoxyglucose F-18
- BIOLOGICAL Rituximab
- OTHER Patient Observation
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
California
- Tower Cancer Research Foundation - Beverly Hills
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- Cedars Sinai Medical Center - Los Angeles
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2038-08-31 |
| Phase | Phase 3 |
What NCT05976763 shows while recruiting
NCT05976763 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (321% higher).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Zanubrutinib is the first listed.
NCT05976763 names 20 study sites across 4 states, led by Connecticut, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT05976763 about?
NCT05976763 is a clinical study titled "Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma". This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody tha...
What is the current status of trial NCT05976763?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 421 participants. The study started on 2023-10-20. Estimated completion is 2038-08-31.
What conditions does trial NCT05976763 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT05976763?
The interventions under investigation include: Zanubrutinib (DRUG), Bone Marrow Biopsy (PROCEDURE), Fludeoxyglucose F-18 (OTHER), Rituximab (BIOLOGICAL), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT05976763?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05976763 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
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 NCT05976763's enrollment target sits among peer trials
421 7th of 102 higher than 96 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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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