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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
Sponsor: Hoffmann-La Roche
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2022-04-25
Completion Date
2027-02-28
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Mosunetuzumab
Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
Rituximab
Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Gemcitabine
Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Oxaliplatin
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Locations (53)
City of Hope Cancer Center
Duarte, California, United States
St. Luke's Hospital
Chesterfield, Missouri, United States
Ascension Seton Infusion Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hospital Aleman
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
FUNDALEU
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
D'or Instituto de Pesquisa e Educação
São Paulo, Brazil
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Chum Hopital Notre Dame
Montreal, Quebec, Canada
Sichuan Cancer Hospital
Chengdu, China
Fujian Medical University Union Hospital
Fuzhou, China
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou, 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
Beersheba, Israel
Ichilov Sourasky Medical Center
Tel Aviv, Israel
Kyushu University Hospital
Fukuoka, Japan
Hokkaido University Hospital
Hokkaido, Japan
Tohoku University Hospital
Miyagi, Japan
Kindai University Hospital
Osaka, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Yamagata University Hospital
Yamagata, Japan
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Superare Centro de Infusion S.A. de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, Mexico
Middlemore Clinical Trials
Auckland, New Zealand
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, Peru
Oncosalud Sac
Lima, Peru
Pusan National University Hospital
Busan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Yeouido St. Mary's Hospital
Seoul, South Korea
Chulalongkorn University Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Chiang Mai Uni Hospital
Chiang Mai, Thailand
Srinagarind Hospital, Khon Kaen Uni
Khon Kaen, Thailand
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, Turkey (Türkiye)
Anadolu Health Center
Kocaeli, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey (Türkiye)