Clinical trialNCT05976763RecruitingPhase 3Interventional

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

SponsorAlliance for Clinical Trials in OncologyEnrollment421Mantle Cell Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

238 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cesar Gentille
Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, United States
Justin M. Darrah
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruiting
City of Hope at Irvine Lennar
Irvine, California, United States
Active, not recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Justin M. Darrah
Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Shalin Kothari
Recruiting
Yale University
New Haven, Connecticut, United States
Shalin Kothari
Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Shalin Kothari
Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Shalin Kothari
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Gregory A. Masters
Recruiting
Medical Oncology Hematology Consultants Pa
Newark, Delaware, United States
Gregory A. Masters
Recruiting
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Locke J. Bryan
Recruiting
Emory Saint Joseph'S Hospital
Atlanta, Georgia, United States
Jonathon B. Cohen →
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Jonathon B. Cohen →
Recruiting
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Jonathon B. Cohen →
Recruiting
Grady Health System
Atlanta, Georgia, United States
Jonathon B. Cohen →
Recruiting
Augusta University Medical Center
Augusta, Georgia, United States
Locke J. Bryan
Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia, United States
Jonathon B. Cohen →
Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Christopher M. Reynolds
Recruiting
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Alison K. Conlin
Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Christopher M. Reynolds
Recruiting
Kootenai Health - Coeur D'Alene
Coeur d'Alene, Idaho, United States
John M. Schallenkamp
Recruiting
Saint Luke'S Cancer Institute - Fruitland
Fruitland, Idaho, United States
Alison K. Conlin
Recruiting
Saint Luke'S Cancer Institute - Meridian
Meridian, Idaho, United States
Alison K. Conlin
Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Christopher M. Reynolds
Recruiting
Saint Luke'S Cancer Institute - Nampa
Nampa, Idaho, United States
Alison K. Conlin
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
John M. Schallenkamp
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
John M. Schallenkamp
Recruiting
Illinois Cancercare-Bloomington
Bloomington, Illinois, United States
Bryan A. Faller
Recruiting
Illinois Cancercare-Canton
Canton, Illinois, United States
Bryan A. Faller
Recruiting
Illinois Cancercare-Carthage
Carthage, Illinois, United States
Bryan A. Faller
Recruiting

198 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Rituximab →Zanubrutinib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Oct 2023
Primary completion: 31 Aug 2038
Completion: 31 Aug 2038
Last update posted: 6 Aug 2026
Registered enrollment: 421
Registry id: NCT05976763

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.