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
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Hospital Alemán
Av. Pueyrredón 1640, CABA, Buenos Aires
Centro de Internación e Investigación Clínica FUNDALEU
J. E. Uriburu 1450, CABA, Buenos Aires
Hospital Privado de Córdoba
Naciones Unidas 346, Córdoba
Hospital de Câncer de Barretos - Fundação PIO XII
Rua Antenor Duarte Villela 1331 - Barretos, Sao Paulo, 14784-400
Hospital Felício Rocho
Av. do Contorno, 9530 - Barro Preto, Belo Horizonte - MG, 30110-934
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
R. Vital Brasil, 251 - Cidade Universitária, Campinas - SP, 13083-888
Hospital Erasto Gaertner
R. Dr. Ovande do Amaral, 201 - Jardim das Américas, Curitiba - PR, 81520-060, Brazil
Instituto Joinvilense de Hematologia e Oncologia (CEPEVILLE)
R. Alexandre Döhler, 129 - Sala 706 - Centro, Joinville - SC, 89201-260, Brazil
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
R. Francisco Getúlio Vargas, 1130 - 315 - Petrópolis, Caxias do Sul - RS, 95070-560, Brazil