Last updated 17 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 (CELESTIAL-RRMCL)
300 patients around the world
Available in Puerto Rico, Brazil, Argentina
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.
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 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.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 (BCL2i).Prior therapy with BTK degraders.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. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.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
Centro de Internación e Investigación Clínica FUNDALEU
Recruiting
Hospital Alemán
Recruiting
Hospital Privado de Córdoba
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
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)
Hospital de Câncer de Pernambuco
Hospital Santa Rita
StudyBGB-11417-302
SponsorBeiGene
Study typeInterventional
Conditions
Mantle cell lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06742996
