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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

April 25, 2022

Primary Completion Date

February 17, 2025

Study Completion Date

February 28, 2027

Conditions
Non-Hodgkin Lymphoma
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).

Trial Locations (52)

41

Oncosalud Sac, Lima

1118

Hospital Aleman, Buenos Aires

1426

Instituto Alexander Fleming, Buenos Aires

5154

Instituto Regional de Enfermedades Neoplásicas del Sur, Arequipa

10330

Chulalongkorn University Hospital, Bangkok

10700

Siriraj Hospital, Bangkok

11550

Superare Centro de Infusion S.A. de C.V., Mexico City

14080

Instituto Nacional de Cancerologia, Distrito Federal

34214

Medipol Mega Üniversite Hastanesi Göztepe, Istanbul

35015

Chungnam National University Hospital, Daejeon

35340

Dokuz Eylul Universitesi Tip Fakultesi, Lzmir

40002

Srinagarind Hospital, Khon Kaen Uni, Khon Kaen

41400

Anadolu Health Center, Kocaeli

49241

Pusan National University Hospital, Busan

50200

Chiang Mai Uni Hospital, Chiang Mai

63017

St. Luke's Hospital, Chesterfield

64460

Hospital Universitario Dr. Jose E. Gonzalez, Monterrey

77030

MD Anderson Cancer Center, Houston

78712

Ascension Seton Infusion Center, Austin

91010

City of Hope Cancer Center, Duarte

300060

Tianjin Cancer Hospital, Tianjin

350001

Fujian Medical University Union Hospital, Fuzhou

430030

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510060

Cancer Center, Sun Yat-sen University of Medical Sciences, Guangzhou

610041

Sichuan Cancer Hospital, Chengdu

6423906

Ichilov Sourasky Medical Center, Tel Aviv

8410101

Soroka Medical Center, Beersheba

C1114AAN

FUNDALEU, Buenos Aires

C1181ACH

Hospital Italiano de Buenos Aires, Ciudad Autonoma Buenos Aires

81520-060

Hospital Erasto Gaertner, Curitiba

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

14048-900

Hospital das Clínicas FMRP-USP, Ribeirão Preto

01323-030

Hospital Sao Jose, São Paulo

Unknown

D'or Instituto de Pesquisa e Educação, São Paulo

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, México

Middlemore Clinical Trials, Auckland

L8V 5C2

Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton

M5G 2M9

Princess Margaret Hospital, Toronto

H2L 4M1

Chum Hopital Notre Dame, Montreal

812-8582

Kyushu University Hospital, Fukuoka

060-8648

Hokkaido University Hospital, Hokkaido

980-8574

Tohoku University Hospital, Miyagi

589-8511

Kindai University Hospital, Osaka

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

990-9585

Yamagata University Hospital, Yamagata

03100

Health Pharma Professional Research, Mexico City

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

07345

Yeouido St. Mary's Hospital, Seoul

06100

Ankara University Medical Faculty, Ankara

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY