A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia mieloide aguda, Linfoma no Hodgkin, Linfoma Folicular, Linfoma
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Raul Cordoba
FECHA DE APERTURA
Abril, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHOHAEM5), 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
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
CRITERIOS DE EXCLUSIÓN
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
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
DESCRIPCIÓN
To demonstrate superiority of sonrotoclax plus zanubrutinib over placebo plus zanubrutinib as measured by progression-free survival (PFS) determined by a blinded independent review committee (BIRC).
PALABRAS CLAVE
diffuse large b-cell lymphoma (dlbcl), non germinal center b-cell type, lymphoma, mantle cell lymphoma, non germinal center b-cell type, ph + acute lymphoblastic leukemia
