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 (Sep 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 rearrangement
evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization [FISH], polymerase chain reaction [PCR]/sequencing, karyotype)
Required: CCND1 expression
cyclin D1 (BCL1) expression by immunohistochemical stains
Required: SOX11 expression
SOX11 expression
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy for mantle cell lymphoma
No prior systemic treatment for mantle cell lymphoma
Cannot have received: radiation therapy for stage I mantle cell lymphoma
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 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days
Kidney function
Creatinine clearance >= 30 mL/min determined by Cockcroft-Gault equation, nuclear medicine scan, or 24 hour urine collection
Liver function
Total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome); AST/ALT <= 3 x ULN
Cardiac function
No unstable angina within 3 months; No NYHA class III or IV CHF; No clinically significant arrhythmias; QTcF > 480 msec excluded unless pacemaker in place; No Mobitz II second-degree or third-degree heart block without permanent pacemaker
Absolute neutrophil count (ANC) >= 750/mm^3 (without growth factor support within 7 days); Platelet count >= 75,000/mm^3 (or >= 50,000/mm^3 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days; Creatinine clearance >= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection; 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; New York Heart Association class III or IV congestive heart failure; History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); Known QT correction formula (QTcF) > 480 msecs based on Fredericia's formula (unless pacemaker in place); History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The James Graham Brown Cancer Center at University of Louisville · Louisville, Kentucky
- UofL Health Medical Center Northeast · Louisville, Kentucky
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor · Ann Arbor, Michigan
- McLaren Cancer Institute-Bay City · Bay City, Michigan
- Trinity Health IHA Medical Group Hematology Oncology - Brighton · Brighton, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05976763 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CCND1?
Yes, CCND1 rearrangement is a required biomarker for enrollment.
Does this trial require CCND1?
Yes, CCND1 expression is a required biomarker for enrollment.
Does this trial require SOX11?
Yes, SOX11 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III or IV is required.
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 qualifyRelated pages