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ACTIVE NOT RECRUITING
NCT05171647
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

Polatuzumab vedotin

Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.

DRUG

Rituximab

Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

DRUG

Gemcitabine

Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

DRUG

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)