RecruitingInterventionalPhase 3

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

NCT ID: NCT06742996Sponsor: BeOne MedicinesLast updated: 2026-06-03

Summary

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.

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.

Arms & interventions

DrugSonrotoclax
Administered orally
DrugZanubrutinib
Administered orally
DrugPlacebo
Administered orally

Outcome measures

Primary

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Approximately 41 months

Secondary

Overall Survival (OS)
Time frame: Approximately 92 months
PFS as assessed by investigator (INV)
Time frame: Approximately 58 months
Overall Response Rate (ORR) as assessed by BIRC and by INV
Time frame: Approximately 58 months
Duration of Response (DOR) as assessed by BIRC and by INV
Time frame: Approximately 58 months
Complete Response Rate (CRR) as assessed by BIRC and by INV
Time frame: Approximately 58 months
Time to first response as assessed by BIRC and by INV
Time frame: Approximately 58 months
Time to initiation of new anticancer therapy
Time frame: Approximately 58 months
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)
Time frame: Approximately 58 months
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Time frame: Approximately 58 months
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (37)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 35294-0004

Recruiting

University of Arizona Cancer Center

Tucson, Arizona, 85724-0001

Recruiting

Ucsf Fresno

Fresno, California, 93701

Recruiting

Kaiser Permanente Southern California

Irvine, California, 92618-3734

Recruiting

Yale University Yale Cancer Center

New Haven, Connecticut, 06520-8028

Recruiting

Memorial Cancer Institute, Memorial Healthcare System

Pembroke Pines, Florida, 33026-4119

Recruiting

Cleveland Clinic Florida

Weston, Florida, 33331-3609

Recruiting

Rush University Medical Center

Chicago, Illinois, 60612

Recruiting

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804

Recruiting

Mission Cancer and Blood

Waukee, Iowa, 50263

Recruiting

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201-1544

Recruiting

Dana Farber Cancer Institute Longwood Medical Center

Boston, Massachusetts, 02215-5418

Recruiting

University of Michigan

Ann Arbor, Michigan, 48109-1382

Recruiting

The Cancer and Hematology Centers

Grand Rapids, Michigan, 49503-2563

Recruiting

Mayo Clinic Rochester

Rochester, Minnesota, 55905-0001

Recruiting

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi, 39401-7233

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110-1010

Recruiting

Nebraska Cancer Specialists St Francis Grand Island

Grand Island, Nebraska, 68803

Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130-2042

Recruiting

The Valley Hospital, Inc

Paramus, New Jersey, 07652

Recruiting

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina, 28204-2990

Recruiting

Duke University

Durham, North Carolina, 27710

Recruiting

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

Recruiting

University Hospitals

Cleveland, Ohio, 44106-1716

Recruiting

Cleveland Clinic Foundation

Cleveland, Ohio, 44195-0001

Recruiting

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1280

Recruiting

Ohio Health Research Institute

Columbus, Ohio, 43214-3907

Recruiting

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033

Recruiting

McGlinn Cancer Institute

West Reading, Pennsylvania, 19611-2143

Recruiting

Tennessee Oncology Nashville St Thomas Midtown Clinic

Nashville, Tennessee, 37205

Recruiting

Tennessee Oncology

Nashville, Tennessee, 37205

Recruiting

Md Anderson Cancer Center

Houston, Texas, 77030-3907

Recruiting

Texas Oncology Austin Midtown

Round Rock, Texas, 78681-4019

Recruiting

University of Virginia

Charlottesville, Virginia, 22908-0817

Recruiting

Virgina Cancer Specialists

Gainesville, Virginia, 20155-3257

Recruiting

Vcu Massey Cancer Center

Richmond, Virginia, 23298-5026

Recruiting

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington, 98684-6930

Recruiting