Last updated 7 days ago
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
300 patients around the world
Available in Puerto Rico, Brazil, Argentina
BeiGene
13Research sites
300Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Mantle cell lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Hospital Alemán
Centro de Internación e Investigación Clínica FUNDALEU
Hospital Privado de Córdoba
Hospital de Câncer de Barretos - Fundação PIO XII
Hospital Felício Rocho
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
Hospital Erasto Gaertner
Instituto Joinvilense de Hematologia e Oncologia (CEPEVILLE)
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
StudyBGB-11417-302
SponsorBeiGene
Study typeInterventional
Conditions
Mantle cell lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06742996
