A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

February 7, 2020

Primary Completion Date

November 29, 2024

Study Completion Date

November 29, 2024

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

Polatuzumab Vedotin

Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.

DRUG

Rituximab

Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.

Trial Locations (67)

10065

Memorial Sloan-Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Cancer Center at Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

MSKCC @ Commack, Commack

14080

Instituto Nacional de Cancerologia, Distrito Federal

28041

Hospital Univ. 12 de Octubre, Madrid

30029

CHU de Nîmes - Hôpital Carémeau, Nîmes

32256

Cancer Specialists, Jacksonville

33028

Memorial Cancer Institute at Memorial West, Pembroke Pines

33520

Tampere University Hospital, Tampere

33604

Hopital De Haut Leveque, Pessac

34093

Istanbul Uni Istanbul Medical Faculty, Istanbul

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34365

Amerikan HAstanesi Onkoloji Birimi Te?vikiye, Ni?anta??

35015

Chungnam National University Hospital, Daejeon

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37044

Hopital Bretonneau, Tours

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

41123

Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia, Modena

41380

Kocaeli Universitesi Tip Fakultesi, Kocaeli

46017

Hospital Universitario Dr. Peset, Valencia

48106

IHA Hematology Oncology Consultants - Ann Arbor, Ann Arbor

49241

Pusan National University Hospital, Busan

52727

Gyeongsang National University Hospital, Gyeongsangnam-do

54100

Sakarya Universitesi Egitim ve Arastirma Hastanesi, Adapazari/Sakarya

59100

USL 4 di Prato - Nuovo Ospeale di Prato, Prato

67200

ICANS, Strasbourg

70124

Uni Degli Studi Di Bari, Policlinico, Bari

76038

Centre Henri Becquerel, Rouen

89081

Universitätsklinikum Ulm, Ulm

90029

Oulu University Hospital, Oulu

94010

Hopital Henri Mondor, Créteil

110029

All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital, New Delhi

300020

Institute of Hematology and Hospital of Blood Disease, Tianjin

330006

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

400013

Tata Memorial Hospital, Mumbai

410006

Hu Nan Provincial Cancer Hospital, Changsha

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

510060

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

530021

Guangxi Cancer Hospital of Guangxi Medical University, Nanning

610047

West China Hospital - Sichuan University, Chengdu

700160

Tata Medical Center, Kolkata

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

59040150

Liga Norte Riograndense Contra O Câncer, Natal

07920

MSKCC at Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering - Monmouth, Middletown

07645

Memorial Sloan Kettering Cancer Center at Bergen, Montvale

41253-190

Hospital Sao Rafael - HSR, Salvador

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

05403-000

Hospital das Clinicas - FMUSP, São Paulo

N6A 5W9

London Health Sciences Centre, London

L2R 7C6

Niagara Health Systems - St. Catherines General Site, St. Catharines

H4A 3J1

McGill University Health Centre - Glen Site, Montreal

G8Z 3R9

Centre hospitalier regional de Trois-Rivieres, Trois-Rivières

115 27

Laiko General Hospital, Athens

124 62

Attiko Hospital, Athens

D08NHY1

St James' Hospital, Dublin

00133

Az. Osp. Uni Ria Policlinico Tor Vergata, Rome

02990

Hospital de Especialidades Centro Medico Nacional La Raza, Mexico City

03100

Health Pharma Professional Research, Mexico City

03722

Severance Hospital, Yonsei University Health System, Seoul

08915

Hospital Universitari Germans Trias i Pujol, Badalona

06200

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital, Ankara

07059

Akdeniz Uni School of Medicine, Antalya

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

SE5 9RS

Kings College Hospital, London

NG5 1PB

Nottingham City Hospital, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04182204 - A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter