RECRUITING

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma

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Conditions

Mantle Cell LymphomaB Cell LymphomaMCLrelapsed/refractory mantle cell lymphomasonrotoclax

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Official Title

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Quick Facts

Study Start:2025-02-25
Study Completion:2032-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06742996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
  2. * Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
  3. * Relapsed or refractory disease after the last line of therapy
  4. * Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  6. * Adequate organ function
  1. * Prior therapy with B-cell lymphoma-2 inhibitor
  2. * Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
  3. * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  4. * Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
  5. * Known central nervous system involvement by lymphoma
  6. * Clinically significant cardiovascular disease
  7. * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294
United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85254
United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
United States
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, 33026
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
United States
Mission Cancer and Blood
Des Moines, Iowa, 50309
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts, 02215
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Ohio Health Research Institute
Columbus, Ohio, 43214
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
United States
Tennessee Oncology
Nashville, Tennessee, 37205
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology Austin Midtown
Round Rock, Texas, 78681
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Virgina Cancer Specialists
Gainesville, Virginia, 20155
United States
Vcu Massey Cancer Center
Richmond, Virginia, 23298
United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25
Study Completion Date2032-10-30

Study Record Updates

Study Start Date2025-02-25
Study Completion Date2032-10-30

Terms related to this study

Keywords Provided by Researchers

  • mantle cell lymphoma
  • MCL
  • relapsed/refractory mantle cell lymphoma
  • sonrotoclax

Additional Relevant MeSH Terms

  • Mantle Cell Lymphoma
  • B Cell Lymphoma