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
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 Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- 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 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: sonrotoclax plus zanubrutinib |
Sonrotoclax and zanubrutinib will be administered in combination. |
|
|
Placebo Comparator Arm B: placebo plus zanubrutinib |
Placebo and zanubrutinib will be administered in combination. |
|
Recruiting Locations
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
Fort Wayne, Indiana 46804
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi 39401-7233
Hattiesburg, Mississippi 39401-7233
Washington University School of Medicine
Saint Louis, Missouri 63110-1010
Saint Louis, Missouri 63110-1010
McGlinn Cancer Institute
West Reading, Pennsylvania 19611-2143
West Reading, Pennsylvania 19611-2143
Tennessee Oncology
Nashville, Tennessee 37205
Nashville, Tennessee 37205
Md Anderson Cancer Center
Houston, Texas 77030-3907
Houston, Texas 77030-3907
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00917
San Juan, Puerto Rico 00917
More Details
- NCT ID
- NCT06742996
- Status
- Recruiting
- Sponsor
- BeiGene