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

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.

Conditions

Mantle Cell Lymphoma, B Cell Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Mantle Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama At Birmingham Hospital, Birmingham, Alabama, United States, 35294

Phoenix

Mayo Clinic Phoenix, Phoenix, Arizona, United States, 85254

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520

Pembroke Pines

Memorial Cancer Institute, Memorial Healthcare System, Pembroke Pines, Florida, United States, 33026

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States, 46804

Des Moines

Mission Cancer and Blood, Des Moines, Iowa, United States, 50309

Baltimore

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

Boston

Dana Farber Cancer Institute Longwood Medical Center, Boston, Massachusetts, United States, 02215

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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
  • * Relapsed or refractory disease after the last line of therapy
  • * 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
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • * Adequate organ function
  • * Prior therapy with B-cell lymphoma-2 inhibitor
  • * 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
  • * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • * Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
  • * Known central nervous system involvement by lymphoma
  • * Clinically significant cardiovascular disease
  • * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2032-10-30