A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
BeOne Medicines
Summary
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugSonrotoclax
Administered orally
- DrugZanubrutinib
Administered orally
- DrugPlacebo
Administered orally
Locations (149)
- University of Alabama At Birmingham HospitalBirmingham, Alabama
- Yale University, Yale Cancer CenterNew Haven, Connecticut
- Memorial Cancer Institute, Memorial Healthcare SystemPembroke Pines, Florida
- Cleveland Clinic FloridaWeston, Florida
- Rush University Medical CenterChicago, Illinois
- Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana