Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT05976763)
A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences — Little Rock, Arkansas
Age range: 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (238 Sites)
Showing the first 25 of 238 sites.
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Tower Cancer Research Foundation — Beverly Hills, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- City of Hope at Irvine Lennar — Irvine, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut
- Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut
- Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
- Yale University — New Haven, Connecticut
- Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut
- Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut
- Helen F Graham Cancer Center — Newark, Delaware
- Medical Oncology Hematology Consultants PA — Newark, Delaware
- Phoebe Putney Memorial Hospital — Albany, Georgia
- Grady Health System — Atlanta, Georgia
- Emory University Hospital Midtown — Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Emory Saint Joseph's Hospital — Atlanta, Georgia
📞 Contact the Study Coordinator
Phone: (919) 966-9268
Email: anne_beaven@med.unc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mantle Cell Lymphoma
- GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma — Rochester, Minnesota
- Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission — Birmingham, Alabama
- Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma — Vancouver, British Columbia
- Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma — Houston, Texas
- Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma — Birmingham, Alabama
- Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL — New York, New York
Explore by condition: All Mantle Cell Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.