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.
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
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
Parallel
Sonrotoclax
DrugAdministered orally
Zanubrutinib
DrugAdministered orally
Placebo
DrugAdministered orally
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.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
PFS as assessed by investigator (INV)
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Overall Response Rate (ORR) as assessed by BIRC and by INV
ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria.
Duration of Response (DOR) as assessed by BIRC and by INV
DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.
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