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Testing Zanubrutinib for Older Patients with Untreated Mantle Cell Lymphoma

This study is for older adults with mantle cell lymphoma (MCL) who haven't been treated before. It's comparing two ways of giving zanubrutinib: continuously (without stopping) or intermittently (stopping and restarting if the cancer comes back). Zanubrutinib works by blocking enzymes that help cancer cells grow. Rituximab, a monoclonal antibody, is also given and may stop cancer cells from growing and spreading. The study wants to see if intermittent treatment can be as effective as continuous treatment, as continuous treatment can have side effects and be costly. Researchers will measure how long patients live without their cancer getting worse (progression-free survival) and overall survival. The study plans to enroll 421 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 421 participants.
What's involved
Participants will receive zanubrutinib (by mouth) and rituximab (by IV). They will also undergo observation, bone marrow biopsies, and receive Fludeoxyglucose F-18 (by IV).
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to 10 years to measure progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05976763

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Recruiting
PHASE3Ages 60+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~421 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:ZanubrutinibRituximabPatient ObservationBone Marrow BiopsyFludeoxyglucose F-18Positron Emission Tomography

At a glance

Recruiting sites
230 of 238 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) 1 (Arm A)
Measured over Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years
+1 more outcome measured

Conditions

Mantle Cell Lymphoma

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Where it's being run

238 sites across 31 states
Michigan32
Illinois29
Wisconsin18
Iowa17
Minnesota16
Missouri16
Connecticut13
Idaho10

Who to contact

Anne Beaven, MD
[email protected]
919-966-9268
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or 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). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma \[MCL\] such as SOX11 expression are also eligible
Any stage allowed (stage I-IV)
Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL
Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration
No prior systemic treatment for mantle cell lymphoma
No prior radiation treatment for stage I MCL
No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody
No prior stem cell transplant
Age \>= 70 years OR age \>= 60 to \< 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \<= 45%, b) diffusing capacity for carbon monoxide \<= 60% predicted; c) creatinine clearance \< 70 but \>= 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \> 6
ECOG Performance Status 0-2
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 upper limit of normal (ULN) (unless documented Gilbert's syndrome)
Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN
Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy
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
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
No history of stroke or intracranial hemorrhage within 6 months prior to registration
No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills
Potential trial participants should have recovered from major surgery
No vaccination with a live vaccine within 35 days prior to registration
No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs
Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.

What this trial measures

  • Progression-free survival (PFS) 1 (Arm A)Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years

    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 using a modified ITT approach, and exclude from the analysis those classified as ineligible as well as those who withdraw right after randomization prior to any treatment/observation monitoring.

  • Progression-free survival (PFS) 2 (Arm B)Time from randomization until the earlier of second progression or death from any cause, assessed up to 10 years

    Hazard ratios on the treatment effect will be estimated using a stratified cox proportional hazards model, stratified on age and MCL IPI score. The primary analysis for non-inferiority will be based on an 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 using a modified ITT approach, and exclude from the analysis those classified as ineligible as well as those who withdraw right after randomization prior to any treatment/observation monitoring.