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
Sponsor: BeiGene
ClinicalTrials ID:NCT06742996
This clinical trial evaluates the efficacy and safety of sonrotoclax plus zanubrutinib versus placebo plus zanubrutinib in adults with relapsed/refractory mantle cell lymphoma. Eligible participants must have a confirmed MCL diagnosis, prior systemic therapy, measurable disease, ECOG status 0-2, and adequate organ function. Interventions include oral administration of sonrotoclax, zanubrutinib, and placebo.
Patient Parameters
| Parameter | Options |
|---|
Program 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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama At Birmingham Hospital | 35294-0004 | Birmingham | Alabama |
| Mayo Clinic Phoenix | 85054-4502 | Phoenix | Arizona |
| Yale University, Yale Cancer Center | 06520-8028 | New Haven | Connecticut |
| Memorial Cancer Institute, Memorial Healthcare System | 33026-4119 | Pembroke Pines | Florida |
| Cleveland Clinic Florida | 33331-3609 | Weston | Florida |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| Mission Cancer and Blood | 50263 | Waukee | Iowa |
| University of Maryland Greenebaum Comprehensive Cancer Center | 21201-1544 | Baltimore | Maryland |
| Dana Farber Cancer Institute Longwood Medical Center | 02215-5418 | Boston | Massachusetts |
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