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Brief Title: A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Official Title: A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Study ID: NCT06084936
Brief Summary: The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Cancer Center, Duarte, California, United States
St. Luke's Hospital, Chesterfield, Missouri, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Calvary Mater Newcastle; Medical Oncology, Waratah, New South Wales, Australia
Royal Adelaide Hospital; Haematology Clinical Trials, Adelaide, South Australia, Australia
Americas Medical City, Rio de Janeiro, RJ, Brazil
Hospital Mae de Deus, Porto Alegre, RS, Brazil
Hospital Paulistano, Sao Paulo, SP, Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil
Instituto D'Or Pesquisa e Ensino, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Beijing Tong Ren Hospital, Capital Medical University, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
West China Hospital of Sichuan University, Chengdu City, , China
Chongqing Cancer Hospital, Chongqing, , China
Fujian Provincial Cancer Hospital, Fuzhou City, , China
Sun yat-sen University Cancer Center; Internal Medicine of Oncology, Guangzhou, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai City, , China
The First Affiliated Hospital of China Medical University, Shenyang City, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou City, , China
Henan Cancer Hospital; Hematology department, Zhengzhou City, , China
The First Affiliated Hospital of Zhengzhou University; Branch Hospital in NEW ZHENGDONG District, Zhengzhou, , China
Hopital Claude Huriez; Hematologie, Lille, , France
Hopital Saint Eloi; Hematologie Oncologie Medicale, Montpellier, , France
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique, Nantes, , France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale., St Cloud, , France
Humanitas Gavazzeni;U.O. Oncologia Medica, Bergamo, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia, Milano, Lombardia, Italy
SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo, Alessandria, Piemonte, Italy
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette; Ematologia I, Torino, Piemonte, Italy
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Universitario Puerta del Mar; Servicio de Hematologia, Cádiz, Cadiz, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia, La Coruna, LA Coruña, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología, Murcia, , Spain
Skånes University Hospital, Skånes Department of Onclology, Lund, , Sweden
Akademiska sjukhuset, Onkologkliniken, Uppsala, , Sweden
National Taiwan Universtiy Hospital; Division of Hematology, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan, , Taiwan
Oxford Churchill Hospital; Cancer and Haematology Centre,Level 2, Oxford, , United Kingdom
Derriford Hospital; Haematology, Plymouth, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR