Trial Title:
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
NCT ID:
NCT06084936
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Obinutuzumab
Lenalidomide
Bendamustine Hydrochloride
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from
Cycle 1 Day 1
Arm group label:
Glofitamab monotherapy
Intervention type:
Drug
Intervention name:
Glofitamab
Description:
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle
length = 21 days).
Arm group label:
Glofitamab monotherapy
Intervention type:
Drug
Intervention name:
Rituximab
Description:
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).
Arm group label:
BR or R-Len
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length
= 28 days).
Arm group label:
BR or R-Len
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease
progression.
Arm group label:
BR or R-Len
Intervention type:
Drug
Intervention name:
Tocilizumab
Description:
Participants will receive IV tocilizumab as required to manage cytokine release syndrome
(CRS) events.
Arm group label:
BR or R-Len
Arm group label:
Glofitamab monotherapy
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Life expectancy at least 12 weeks
- Histologically-confirmed MCL, with documentation of either overexpression of cyclin
D1 or the presence of t(11:14)
- Relapsed (disease progression after the last treatment regimen) or refractory
(failure to achieve a partial or complete response from the last treatment regimen)
disease
- At least 1 line of prior systemic therapy including a BTK inhibitor and additional
systemic therapy option
- Confirmed availability of tumor tissue, unless deemed unsafe per investigator
assessment
- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion,
or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on
CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate hematological function
Exclusion Criteria:
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or
within 3 months after the final dose of tocilizumab, 2 months after the final dose
of glofitamab, whichever is longer
- Leukemic, non-nodal MCL
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies (or recombinant antibody-related fusion proteins) or known
sensitivity or allergy to murine products
- Contraindication to obinutuzumab or rituximab, and either bendamustine or
lenalidomide
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20
and CD3
- Prior treatment with CAR-T cell therapy
- Treatment with systemic therapy or BTK inhibitors, or any investigational agent for
the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is
shorter) prior to first study treatment
- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS
lymphoma
- Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or
neurodegenerative disease
- History of other malignancy that could affect compliance with the protocol or
interpretation of results
- Significant or extensive cardiovascular disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
at study enrollment or any major episode of infection within 4 weeks prior to the
first study treatment
- Suspected or latent tuberculosis
- Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known or suspected chronic active Epstein-Barr viral infection (EBV)
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy (PML)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or
better
- Administration of a live, attenuated vaccine within 4 weeks before first study
treatment administration or anticipation that such a live, attenuated vaccine will
be required during the study
- Prior solid organ transplantation or allogenic stem cell transplant
- Eligibility for stem cell transplantation (SCT)
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 2 weeks or five
half-lives (whichever is shorter) prior to the first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment
- Recent major surgery (within 4 weeks before the first study treatment) other than
for diagnosis
- Clinically significant history of cirrhotic liver disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alta Bates Summit Medical Center; Comprehensive Cancer Center
Address:
City:
Berkeley
Zip:
94704
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Luke's Hospital
Address:
City:
Chesterfield
Zip:
63017
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Facility:
Name:
West Virginia University
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Facility:
Name:
Calvary Mater Newcastle; Medical Oncology
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Adelaide Hospital; Haematology Clinical Trials
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Hospital
Address:
City:
Richmond
Zip:
3121
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hospital Sao Rafael - HSR
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
ICTR Curitiba
Address:
City:
Curitiba
Zip:
80510-130
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Americas Medical City
Address:
City:
Rio de Janeiro
Zip:
22775-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Mae de Deus
Address:
City:
Porto Alegre
Zip:
90110-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Paulistano
Address:
City:
Sao Paulo
Zip:
01321-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Alemao Oswaldo Cruz
Address:
City:
Sao Paulo
Zip:
01327-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital A. C. Camargo; Oncologia
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto D'Or Pesquisa e Ensino
Address:
City:
Sao Paulo
Zip:
04502-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Beneficencia Portuguesa de Sao Paulo
Address:
City:
São Paulo
Zip:
01321-00
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Victoria Hospital - London Health Sciences Centre
Address:
City:
London
Zip:
N6A 4G5
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Beijing Tong Ren Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun City
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu City
Zip:
610041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou City
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Sun yat-sen University Cancer Center; Internal Medicine of Oncology
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Guangxi Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning City
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center; Medical Oncology
Address:
City:
Shanghai City
Zip:
201315
Country:
China
Status:
Active, not recruiting
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
Shenyang City
Zip:
110001
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou City
Zip:
325035
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Henan Cancer Hospital; Hematology department
Address:
City:
Zhengzhou City
Zip:
450008
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University; Branch Hospital in NEW ZHENGDONG District
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Facility:
Name:
Hopital Claude Huriez; Hematologie
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Eloi; Hematologie Oncologie Medicale
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Necker; Hematologie Clinique Adulte
Address:
City:
Paris
Zip:
75743
Country:
France
Status:
Recruiting
Facility:
Name:
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Address:
City:
St Cloud
Zip:
92210
Country:
France
Status:
Recruiting
Facility:
Name:
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Humanitas Gavazzeni;U.O. Oncologia Medica
Address:
City:
Bergamo
Zip:
24121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo
Address:
City:
Alessandria
Zip:
15121
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette; Ematologia I
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Chungnam National University Hospital
Address:
City:
Daejeon
Zip:
35015
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario Puerta del Mar; Servicio de Hematologia
Address:
City:
Cádiz
Zip:
11009
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
Address:
City:
La Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Skånes University Hospital, Skånes Department of Onclology
Address:
City:
Lund
Zip:
221 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Akademiska sjukhuset, Onkologkliniken
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
National Taiwan Universtiy Hospital; Division of Hematology
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital; Internal Medicine
Address:
City:
Taipei
Country:
Taiwan
Status:
Withdrawn
Facility:
Name:
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Oxford Churchill Hospital; Cancer and Haematology Centre,Level 2
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Derriford Hospital; Haematology
Address:
City:
Plymouth
Zip:
PL6 8DH
Country:
United Kingdom
Status:
Recruiting
Start date:
October 22, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084936
