A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

February 15, 2026

Study Completion Date

February 15, 2026

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Obinutuzumab

Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.

DRUG

Glofitamab

Participants will receive IV glofitamab for up to 12 cycles.

DRUG

Rituxumab

Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).

DRUG

Gemcitabine

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

DRUG

Oxaliplatin

Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.

Trial Locations (62)

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

833

Chang Gung Medical Foundation - Kaohsiung;Oncology, Kaoisung

2031

Prince of Wales Hospital, Randwick

2100

Rigshospitalet, København Ø

3000

Peter Maccallum Cancer Centre, Melbourne

UZ Leuven Gasthuisberg, Leuven

3010

Inselspital Bern, Insel-Gruppe AG, Bern

3065

St Vincent's Hospital Melbourne, Fitzroy

3168

Monash Health Monash Medical Centre, Clayton

4000

CHU de Liège (Sart Tilman), Liège

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

8091

Universitätsspital Zürich, Zurich

8200

Aarhus Universitetshospital Skejby, Aarhus N

10029

Icahn School of Medicine at Mount Sinai, New York

10408

National Cancer Center, Goyang-si

13605

Seoul National University Bundang Hospital, Seongnam-si

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

27705

Duke University Medical Center, Durham

28046

Hospital Universitario la Paz, Madrid

32207

Baptist - MD Anderson Cancer Center, Jacksonville

33076

Institut Bergonie, Bordeaux

34295

Chu de Montpellier-St Eloi, Montpellier

35003

CHU Pontchaillou, Rennes

35392

Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I, Giessen

39216

University of Mississippi Medical Center, Jackson

40705

Taichung Veterans General Hospital, Xitun Dist.

41013

Hospital Universitario Virgen del Rocio, Seville

46010

Hospital Clinico Universitario de Valencia, Valencia

49241

Pusan National University Hospital, Busan

59037

Hopital Claude Huriez, Lille

60590

Universitatsklinikum Frankfurt, Frankfurt

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

93053

Universitaetsklinikum Regensburg, Regensburg

93720

Community Cancer Institute (CCI), Fresno

94010

Hopital Henri Mondor, Créteil

100083

Peking University Third Hospital, Beijing

150081

Harbin Medical University Cancer Hospital, Harbin

200120

Fudan University Shanghai Cancer Center, Shanghai

300060

Tianjin Cancer Hospital, Tianjin

310022

Zhejiang Cancer Hospital, Zhejiang

430022

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

450008

Henan Cancer Hospital, Zhengzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

35294-3300

University of Alabama at Birmingham, Birmingham

02114

Massachusetts General Hospital, Boston

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

20-090

Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli, Lublin

10-228

Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroc?aw

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

G12 OYN

Beatson West of Scotland Cancer Centre, Glasgow

LS9 7TF

St James's Institute of Oncology, Leeds

NW1 2PG

UCLH - Clinical Trials Pharmacy B&D Centre, London

M20 4BX

Christie Hospital, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY