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Brief Title: A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Official Title: A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT05171647
Brief Summary: This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alaska Oncology & Hematology, LLC, Anchorage, Alaska, United States
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics, Duarte, California, United States
Kaiser Permanente - Irvine, Irvine, California, United States
Cancer Blood and Specialty Clinic, Los Alamitos, California, United States
USC School of Medicine, Los Angeles, California, United States
University of Miami - Clinical Research Services, Miami, Florida, United States
Investigative Clinical Research of Indiana, LLC, Noblesville, Indiana, United States
St. Luke's Hospital, Chesterfield, Missouri, United States
Levine Cancer Institute - Clincal Trials Administration, Charlotte, North Carolina, United States
Rhode Island Hospital; Comprehensive Cancer Center, Providence, Rhode Island, United States
Ascension Seton Infusion Center, Austin, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Instituto Alexander Fleming, Buenos Aires, , Argentina
Fundaleu; Haematology, Buenos Aires, , Argentina
Hospital Aleman, Ciudad Autonoma Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires, , Argentina
Hospital Erasto Gaertner, Curitiba, PR, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital das Clínicas FMRP-USP, Ribeirao Preto, SP, Brazil
Hospital Sao Jose, Sao Paulo, SP, Brazil
D'or Instituto de Pesquisa e Educação, Sao Paulo, SP, Brazil
Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Hospital; Department of Med Oncology, Toronto, Ontario, Canada
Chum Hopital Notre Dame; Centre D'Oncologie, Montreal, Quebec, Canada
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC), Saskatoon, Saskatchewan, Canada
Sichuan Cancer Hospital, Chengdu City, , China
Fujian Medical University Union Hospital, Fuzhou City, , China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology, Guangzhou City, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, , China
The Second Affiliated Hospital to Nanchang University, Nanchang, , China
Tianjin Cancer Hospital, Tianjin, , China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
Soroka Medical Center; Hematology Deptartment, Beer Sheva, , Israel
Meir Medical Center; Heamatology Dept, Kfar Saba, , Israel
Ichilov Sourasky Medical Center; Heamatology, Tel Aviv, , Israel
Kyushu University Hospital, Fukuoka, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
Kobe City Medical Center General Hospital, Hyogo, , Japan
Tokai University Hospital, Kanagawa, , Japan
Mie University Hospital, Mie, , Japan
Tohoku University Hospital, Miyagi, , Japan
Kindai University Hospital, Osaka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
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
Samsung Medical Center, Seoul, , Korea, Republic of
Yeouido St. Mary's Hospital, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Superare Centro de Infusion S.A. de C.V., Mexico, Mexico CITY (federal District), Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology, Monterrey, Nuevo LEON, Mexico
Instituto Nacional de Cancerologia; Oncology, Mexico City, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, , Mexico
Middlemore Clinical Trials, Auckland, , New Zealand
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica, Arequipa, , Peru
Hospital Nacional Edgardo Rebagliati Martins, Servicio de Gastroenterologia, Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Oncosalud Sac; Oncología, Lima, , Peru
Hospital De Alta Complejidad Virgen De La Puerta - Essalud; Oncology, Trujillo, , Peru
Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod, Niznij Novgorod, Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Chulalongkorn University Hospital; Hematology, Bangkok, , Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine, Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine, Khon Kaen, , Thailand
Ankara University Medical Faculty, Ankara, , Turkey
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul, , Turkey
Anadolu Health Center; Heamathology Department, Kocaeli, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Lzmir, , Turkey
Ondokuz Mayis Univ. Med. Fac., Samsun, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR