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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
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06742996.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not Available
Stamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center