A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
NCT ID: NCT06084936
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
182 participants
INTERVENTIONAL
2023-10-22
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glofitamab monotherapy
Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
BR or R-Len
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
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).
Bendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Interventions
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Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
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).
Bendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Eligibility Criteria
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Inclusion Criteria
* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alta Bates Summit Medical Center
Berkeley, California, United States
City of Hope Cancer Center
Duarte, California, United States
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Miami
Coral Gables, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
St. Luke's Hospital
Chesterfield, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Rochester
Rochester, New York, United States
Medical University of S. Carolina
Charleston, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Epworth Hospital
Richmond, Victoria, Australia
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
ICTR Curitiba
Curitiba, Paraná, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Paulistano
São Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital A. C. Camargo
São Paulo, São Paulo, Brazil
Instituto D'Or Pesquisa e Ensino
São Paulo, São Paulo, Brazil
Americas Medical City
Rio de Janeiro, , Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, , Brazil
Victoria Hospital - London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Beijing Tong Ren Hospital, Capital Medical University
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital of Sichuan University
Chengdu, , China
Chongqing Cancer Hospital
Chongqing, , China
Fujian Provincial Cancer Hospital
Fuzhou, , China
Sun yat-sen University Cancer Center
Guangzhou, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
Hopital Claude Huriez
Lille, , France
Hopital Saint Eloi
Montpellier, , France
CHU NANTES - Hôtel Dieu
Nantes, , France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Paris, , France
Hopital Necker
Paris, , France
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Humanitas Gavazzeni
Bergamo, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo
Alessandria, Piedmont, Italy
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette
Turin, Piedmont, Italy
Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Chungnam National University Hospital
Daejeon, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Puerta del Mar
Cadiz, Cadiz, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario J.M Morales Meseguer
Murcia, , Spain
Skånes University Hospital, Skånes Department of Onclology
Lund, , Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, , Sweden
National Taiwan Universtiy Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Lincolnshire County Hospital
Lincoln, , United Kingdom
University College London Hospital
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Oxford Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: GO43878 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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GO43878
Identifier Type: -
Identifier Source: org_study_id
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