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Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT05976763 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05976763
The ClinicalTrials.gov registry entry for NCT05976763 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 421 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05976763 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Connecticut, California, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05976763?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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