OncoMatch/Clinical Trials/NCT05976763
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
Is NCT05976763 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Rituximab and Zanubrutinib for mantle cell lymphoma.
Treatment: Zanubrutinib · Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
cyclin D1 (BCL1) expression by immunohistochemical stains
Required: IGH t(11;14)
t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
No prior systemic treatment for mantle cell lymphoma
Cannot have received: radiation therapy
Exception: except for stage I MCL
No prior radiation treatment for stage I MCL
Cannot have received: BTK inhibitor
No prior exposure to a BTK inhibitor
Cannot have received: anti-CD20 monoclonal antibody
No prior exposure to an anti-CD20 monoclonal antibody
Cannot have received: stem cell transplant
No prior stem cell transplant
Lab requirements
Blood counts
ANC >= 750/mm^3 (without growth factor support within 7 days); Platelet count >= 75,000/mm^3 (or >= 50,000/mm^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days
Kidney function
Creatinine clearance >= 30 mL/min determined by either estimation (Cockcroft-Gault) or measurement
Liver function
Total bilirubin <= 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); AST/ALT <= 3 x ULN
Cardiac function
No clinically significant cardiovascular disease including: unstable angina within 3 months, NYHA class III or IV CHF, history of clinically significant arrhythmias, QTcF > 480 msecs, history of Mobitz II second-degree or third-degree heart block without a permanent pacemaker
ANC >= 750/mm^3 (without growth factor support within 7 days); Platelet count >= 75,000/mm^3 (or >= 50,000/mm^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days; Creatinine clearance >= 30 mL/ min; Total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome); AST/ALT <= 3 x ULN; No clinically significant cardiovascular disease including the following: unstable angina within 3 months before registration, NYHA class III or IV CHF, history of clinically significant arrhythmias, QTcF > 480 msecs, history of Mobitz II second-degree or third-degree heart block without a permanent pacemaker
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify