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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

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

More Details

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.