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RECRUITING

NCT05976763

PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

421

Start Date

2023-10-20

Completion Date

2038-08-31

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Mantle Cell Lymphoma

Interventions

DRUG

Zanubrutinib

Given PO

BIOLOGICAL

Rituximab

Given IV

OTHER

Patient Observation

Undergo observation

PROCEDURE

Bone Marrow Biopsy

undergo bone marrow biopsy

OTHER

Fludeoxyglucose F-18

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

PROCEDURE

Colonoscopy

Undergo colonoscopy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * • 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.

Locations (242)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Alliance for Clinical Trials in Oncology

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Northwest Cancer Center - Crown Point

Crown Point, Indiana, United States

Northwest Oncology LLC

Dyer, Indiana, United States

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Saint Mary Medical Center

Hobart, Indiana, United States

Saint Catherine Hospital

Indianapolis, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Women's Diagnostic Center - Munster

Munster, Indiana, United States

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center