Brief 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 lymphomacancers of the lymphatic system (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
Intervention / Treatment
- Drug: Sonrotoclax
- Drug: Zanubrutinib
- Drug: Placebo
Inclusion Criteria:
- Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses (mAb)-based immunotherapya treatment that uses a person's immune system to fight cancer 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 to 2
- Adequate organ function