A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

October 22, 2023

Primary Completion Date

February 26, 2027

Study Completion Date

September 30, 2027

Conditions
Lymphoma
Interventions
DRUG

Obinutuzumab

Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1

DRUG

Glofitamab

Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).

DRUG

Rituximab

Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).

DRUG

Bendamustine

Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).

DRUG

Lenalidomide

Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.

DRUG

Tocilizumab

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

Trial Locations (75)

100

RECRUITING

National Taiwan Universtiy Hospital, Taipei

333

RECRUITING

Chang Gung Medical Foundation - Linkou, Taoyuan District

2298

RECRUITING

Calvary Mater Newcastle, Waratah

3121

RECRUITING

Epworth Hospital, Richmond

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

10126

RECRUITING

A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette, Turin

11009

RECRUITING

Hospital Universitario Puerta del Mar, Cadiz

14642

RECRUITING

University of Rochester, Rochester

15006

RECRUITING

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

15121

RECRUITING

SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo, Alessandria

20007

RECRUITING

Georgetown University, Washington D.C.

20141

RECRUITING

Irccs Istituto Europeo Di Oncologia (IEO), Milan

22906

RECRUITING

University of Virginia, Charlottesville

24121

RECRUITING

Humanitas Gavazzeni, Bergamo

26506

RECRUITING

West Virginia University, Morgantown

29425

RECRUITING

Medical University of S. Carolina, Charleston

30008

RECRUITING

Hospital General Universitario J.M Morales Meseguer, Murcia

33146

RECRUITING

University of Miami, Coral Gables

34295

RECRUITING

Hopital Saint Eloi, Montpellier

35015

WITHDRAWN

Chungnam National University Hospital, Daejeon

40138

ACTIVE_NOT_RECRUITING

Policlinico S.Orsola-Malpighi, Bologna

44093

RECRUITING

CHU NANTES - Hôtel Dieu, Nantes

46202

WITHDRAWN

Indiana University, Indianapolis

48109

RECRUITING

University of Michigan Health System, Ann Arbor

57105

WITHDRAWN

Avera Cancer Institute, Sioux Falls

59037

RECRUITING

Hopital Claude Huriez, Lille

63017

RECRUITING

St. Luke's Hospital, Chesterfield

75005

RECRUITING

INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale., Paris

75743

RECRUITING

Hopital Necker, Paris

77380

RECRUITING

Renovatio Clinical, The Woodlands

79915

RECRUITING

Renovatio Clinical - El Paso, El Paso

91010

RECRUITING

City of Hope Cancer Center, Duarte

94704

WITHDRAWN

Alta Bates Summit Medical Center, Berkeley

100730

RECRUITING

Beijing Tong Ren Hospital, Capital Medical University, Beijing

110001

RECRUITING

The First Affiliated Hospital of China Medical University, Shenyang

130021

RECRUITING

The First Hospital of Jilin University, Changchun

200032

ACTIVE_NOT_RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

325035

COMPLETED

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

350014

RECRUITING

Fujian Provincial Cancer Hospital, Fuzhou

400030

RECRUITING

Chongqing Cancer Hospital, Chongqing

450003

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

450008

RECRUITING

Henan Cancer Hospital, Zhengzhou

510060

ACTIVE_NOT_RECRUITING

Sun yat-sen University Cancer Center, Guangzhou

530021

RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University, Nanning

610041

ACTIVE_NOT_RECRUITING

West China Hospital of Sichuan University, Chengdu

90404-2023

RECRUITING

University of California Los Angeles (UCLA) - Cancer Care - Santa Monica, Santa Monica

06520

RECRUITING

Yale Cancer Center, New Haven

08901

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

41253-190

RECRUITING

Hospital Sao Rafael - HSR, Salvador

80510-130

RECRUITING

ICTR Curitiba, Curitiba

90110-000

RECRUITING

Hospital Mae de Deus, Porto Alegre

01321-000

RECRUITING

Hospital Paulistano, São Paulo

01327-001

RECRUITING

Hospital Alemao Oswaldo Cruz, São Paulo

01509-010

RECRUITING

Hospital A. C. Camargo, São Paulo

04502-001

RECRUITING

Instituto D'Or Pesquisa e Ensino, São Paulo

22775-001

RECRUITING

Americas Medical City, Rio de Janeiro

01321-00

RECRUITING

Beneficencia Portuguesa de Sao Paulo, São Paulo

N6A 5W9

RECRUITING

Victoria Hospital - London Health Sciences Centre, London

K1H 8L6

RECRUITING

The Ottawa Hospital - General Campus, Ottawa

M5G 2M9

RECRUITING

Princess Margaret Cancer Center, Toronto

00918

RECRUITING

Auxilio Mutuo Cancer Center, San Juan

003-722

ACTIVE_NOT_RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

03080

ACTIVE_NOT_RECRUITING

Seoul National University Hospital, Seoul

05505

ACTIVE_NOT_RECRUITING

Asan Medical Center, Seoul

135-710

ACTIVE_NOT_RECRUITING

Samsung Medical Center, Seoul

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

221 85

RECRUITING

Skånes University Hospital, Skånes Department of Onclology, Lund

751 85

RECRUITING

Akademiska sjukhuset, Onkologkliniken, Uppsala

G12 0YN

RECRUITING

NHS Greater Glasgow and Clyde, Glasgow

LN2 5QY

RECRUITING

Lincolnshire County Hospital, Lincoln

NW1 2PG

RECRUITING

University College London Hospital, London

M2O 4BX

RECRUITING

Christie Hospital Nhs Trust, Manchester

OX3 7LE

RECRUITING

Oxford Churchill Hospital, Oxford

PL6 8DH

RECRUITING

Derriford Hospital, Plymouth

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY