Actively Recruiting
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Led by Hoffmann-La Roche · Updated on 2026-05-04
182
Participants Needed
76
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
CONDITIONS
Official Title
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy at least 12 weeks
- Histologically-confirmed mantle cell lymphoma with cyclin D1 overexpression or t(11:14) within 12 months
- Relapsed or refractory disease after prior treatment
- At least 1 prior systemic therapy including a BTK inhibitor and another systemic option
- Availability of tumor tissue unless unsafe
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1 cm) on CT scan
- ECOG performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate blood function
You will not qualify if you...
- Pregnancy, breastfeeding, or planning pregnancy during study or specified time after last treatment
- Leukemic, non-nodal mantle cell lymphoma
- Severe allergic or anaphylactic reactions to certain monoclonal antibodies or murine products
- Contraindications to obinutuzumab or rituximab, and bendamustine or lenalidomide
- Prior treatment with glofitamab or similar bispecific antibodies
- Prior CAR-T cell therapy
- Recent systemic cancer treatment or investigational agent within 2 weeks or 5 half-lives before study
- Current or history of CNS lymphoma or CNS disease such as stroke or epilepsy
- History of other malignancies affecting study compliance
- Significant cardiovascular disease
- Active or recent major infection
- Suspected or latent tuberculosis
- Positive hepatitis B or C test
- Known chronic active Epstein-Barr virus infection
- History of hemophagocytic lymphohistiocytosis or progressive multifocal leukoencephalopathy
- Unresolved adverse events from prior cancer therapy
- Recent live vaccine administration
- Prior organ or stem cell transplant
- Eligibility for stem cell transplantation
- Active autoimmune disease requiring treatment
- Recent immunosuppressive or corticosteroid therapy
- Recent major surgery
- History of cirrhotic liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
Withdrawn
2
City of Hope Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States, 90404-2023
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
University of Miami
Coral Gables, Florida, United States, 33146
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Withdrawn
8
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
Actively Recruiting
10
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
11
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
12
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
13
Medical University of S. Carolina
Charleston, South Carolina, United States, 29425
Withdrawn
14
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Withdrawn
15
Renovatio Clinical - El Paso
El Paso, Texas, United States, 79915
Actively Recruiting
16
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Actively Recruiting
17
University of Virginia
Charlottesville, Virginia, United States, 22906
Actively Recruiting
18
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
19
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
20
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
21
Epworth Hospital
Richmond, Victoria, Australia, 3121
Actively Recruiting
22
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil, 41253-190
Withdrawn
23
ICTR Curitiba
Curitiba, Paraná, Brazil, 80510-130
Actively Recruiting
24
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil, 90110-000
Actively Recruiting
25
Hospital Paulistano
São Paulo, São Paulo, Brazil, 01321-000
Actively Recruiting
26
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil, 01327-001
Actively Recruiting
27
Hospital A. C. Camargo
São Paulo, São Paulo, Brazil, 01509-010
Actively Recruiting
28
Instituto D'Or Pesquisa e Ensino
São Paulo, São Paulo, Brazil, 04502-001
Actively Recruiting
29
Americas Medical City
Rio de Janeiro, Brazil, 22775-001
Actively Recruiting
30
Beneficencia Portuguesa de Sao Paulo
São Paulo, Brazil, 01321-00
Actively Recruiting
31
Victoria Hospital - London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
32
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
33
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
34
Beijing Tong Ren Hospital, Capital Medical University
Beijing, China, 100730
Actively Recruiting
35
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
36
West China Hospital of Sichuan University
Chengdu, China, 610041
Active, Not Recruiting
37
Chongqing Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
38
Fujian Provincial Cancer Hospital
Fuzhou, China, 350014
Actively Recruiting
39
Sun yat-sen University Cancer Center
Guangzhou, China, 510060
Active, Not Recruiting
40
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China, 530021
Actively Recruiting
41
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Active, Not Recruiting
42
The First Affiliated Hospital of China Medical University
Shenyang, China, 110001
Actively Recruiting
43
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325035
Completed
44
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450003
Actively Recruiting
45
Henan Cancer Hospital
Zhengzhou, China, 450008
Actively Recruiting
46
Hopital Claude Huriez
Lille, France, 59037
Actively Recruiting
47
Hopital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
48
CHU NANTES - Hôtel Dieu
Nantes, France, 44093
Actively Recruiting
49
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Paris, France, 75005
Actively Recruiting
50
Hopital Necker
Paris, France, 75743
Actively Recruiting
51
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
52
Humanitas Gavazzeni
Bergamo, Lombardy, Italy, 24121
Actively Recruiting
53
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy, 20141
Actively Recruiting
54
SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo
Alessandria, Piedmont, Italy, 15121
Actively Recruiting
55
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette
Turin, Piedmont, Italy, 10126
Actively Recruiting
56
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00918
Actively Recruiting
57
Chungnam National University Hospital
Daejeon, South Korea, 35015
Withdrawn
58
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 003-722
Active, Not Recruiting
59
Seoul National University Hospital
Seoul, South Korea, 03080
Completed
60
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
61
Samsung Medical Center
Seoul, South Korea, 135-710
Active, Not Recruiting
62
Hospital Universitario Puerta del Mar
Cadiz, Cadiz, Spain, 11009
Actively Recruiting
63
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain, 15006
Actively Recruiting
64
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
65
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
66
Hospital General Universitario J.M Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
67
Skånes University Hospital, Skånes Department of Onclology
Lund, Sweden, 221 85
Actively Recruiting
68
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 751 85
Actively Recruiting
69
National Taiwan Universtiy Hospital
Taipei, Taiwan, 100
Actively Recruiting
70
Chang Gung Medical Foundation - Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
71
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
72
Lincolnshire County Hospital
Lincoln, United Kingdom, LN2 5QY
Actively Recruiting
73
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
74
Christie Hospital Nhs Trust
Manchester, United Kingdom, M2O 4BX
Actively Recruiting
75
Oxford Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
76
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
R
Reference Study ID Number: GO43878 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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