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 (CELESTIAL-RRMCL)

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) - Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis - 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

Exclusion Criteria

  • Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i) - Prior therapy with BTK degraders - 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. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible. - 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: sonrotoclax plus zanubrutinib 		Sonrotoclax and zanubrutinib will be administered in combination.
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
  • Drug: Zanubrutinib
    Administered orally
    Other names:
    • Brukinsa
    • BGB-3111
Placebo Comparator
Arm B: placebo plus zanubrutinib 		Placebo and zanubrutinib will be administered in combination.
  • Drug: Zanubrutinib
    Administered orally
    Other names:
    • Brukinsa
    • BGB-3111
  • Drug: Placebo
    Administered orally

Recruiting Locations

University of Alabama At Birmingham Hospital
Birmingham 4049979, Alabama 4829764 35294-0004

Mayo Clinic Phoenix
Phoenix 5308655, Arizona 5551752 85054-4502

Yale University, Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520-8028

Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines 4168139, Florida 4155751 33026-4119

Cleveland Clinic Florida
Weston 4178003, Florida 4155751 33331-3609

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

Fort Wayne Medical Oncology and Hematology
Fort Wayne 4920423, Indiana 4921868 46804

Mission Cancer and Blood
Waukee 4880981, Iowa 4862182 50263

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21201-1544

Dana Farber Cancer Institute Longwood Medical Center
Boston 4930956, Massachusetts 6254926 02215-5418

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-1382

The Cancer and Hematology Centers
Grand Rapids 4994358, Michigan 5001836 49503-2563

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905-0001

Hattiesburg Hematology and Oncology Clinic
Hattiesburg 4429295, Mississippi 4436296 39401-7233

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010

Nebraska Cancer Specialists St Francis Grand Island
Grand Island 5069297, Nebraska 5073708 68803

Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130-2042

The Valley Hospital, Inc
Paramus 5102387, New Jersey 5101760 07652

Atrium Health Levine Cancer Institute (Lci)
Charlotte 4460243, North Carolina 4482348 28204-2990

Duke University
Durham 4464368, North Carolina 4482348 27710

Atrium Health Wake Forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27157

University Hospitals
Cleveland 5150529, Ohio 5165418 44106-1716

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195-0001

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210-1280

Ohio Health Research Institute
Columbus 4509177, Ohio 5165418 43214-3907

Penn State Milton S Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033

McGlinn Cancer Institute
West Reading 5218867, Pennsylvania 6254927 19611-2143

Tennesse Oncology Chattanooga Downtown
Chattanooga 4612862, Tennessee 4662168 37404

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37205

Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-3907

Texas Oncology Austin Midtown
Round Rock 4724129, Texas 4736286 78681-4019

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908-0817

Virgina Cancer Specialists
Gainesville 4760363, Virginia 6254928 20155-3257

Vcu Massey Cancer Center
Richmond 4781708, Virginia 6254928 23298-5026

Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver 5814616, Washington 5815135 98684-6930

Auxilio Mutuo Cancer Center
San Juan 4568127, Puerto Rico 00917

More Details

NCT ID
NCT06742996
Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
1.877.828.5568
clinicaltrials@beonemed.com

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center