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A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
NCT06084936 · Hoffmann-La Roche
In plain English
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Official title
A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma
About this study
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).
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) 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:
* 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
Study design
Enrollment target: 182 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-22
Estimated completion: 2028-03-31
Last updated: 2026-04-02
Interventions
Drug: ObinutuzumabDrug: GlofitamabDrug: RituximabDrug: BendamustineDrug: LenalidomideDrug: Tocilizumab
Primary outcomes
- • Progression-free survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months))
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: GO43878 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (75)
Alta Bates Summit Medical CenterWithdrawn
Berkeley, California, United States
City of Hope Cancer CenterRecruiting
Duarte, California, United States
University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaRecruiting
Santa Monica, California, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
University of MiamiRecruiting
Coral Gables, Florida, United States
Indiana UniversityWithdrawn
Indianapolis, Indiana, United States
University of Michigan Health SystemRecruiting
Ann Arbor, Michigan, United States
St. Luke's HospitalRecruiting
Chesterfield, Missouri, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
University of RochesterRecruiting
Rochester, New York, United States
Medical University of S. CarolinaWithdrawn
Charleston, South Carolina, United States
Avera Cancer InstituteWithdrawn
Sioux Falls, South Dakota, United States
Renovatio Clinical - El PasoRecruiting
El Paso, Texas, United States
Renovatio ClinicalRecruiting
The Woodlands, Texas, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
Calvary Mater NewcastleRecruiting
Waratah, New South Wales, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Epworth HospitalRecruiting
Richmond, Victoria, Australia
Hospital Sao Rafael - HSRWithdrawn
Salvador, Estado de Bahia, Brazil
ICTR CuritibaRecruiting
Curitiba, Paraná, Brazil
Hospital Mae de DeusRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital PaulistanoRecruiting
São Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo CruzRecruiting
São Paulo, São Paulo, Brazil
Hospital A. C. CamargoRecruiting
São Paulo, São Paulo, Brazil
Instituto D'Or Pesquisa e EnsinoRecruiting
São Paulo, São Paulo, Brazil
Americas Medical CityRecruiting
Rio de Janeiro, Brazil
Beneficencia Portuguesa de Sao PauloRecruiting
São Paulo, Brazil
Victoria Hospital - London Health Sciences CentreRecruiting
London, Ontario, Canada
The Ottawa Hospital - General CampusRecruiting
Ottawa, Ontario, Canada
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada
Beijing Tong Ren Hospital, Capital Medical UniversityRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
West China Hospital of Sichuan UniversityActive Not Recruiting
Chengdu, China
Chongqing Cancer HospitalRecruiting
Chongqing, China
Fujian Provincial Cancer HospitalRecruiting
Fuzhou, China
Sun yat-sen University Cancer CenterActive Not Recruiting
Guangzhou, China
Guangxi Cancer Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
Fudan University Shanghai Cancer CenterActive Not Recruiting
Shanghai, China
The First Affiliated Hospital of China Medical UniversityRecruiting
Shenyang, China
The First Affiliated Hospital of Wenzhou Medical UniversityCompleted
Wenzhou, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, China
Henan Cancer HospitalRecruiting
Zhengzhou, China
Hopital Claude HuriezRecruiting
Lille, France
Hopital Saint EloiRecruiting
Montpellier, France
CHU NANTES - Hôtel DieuRecruiting
Nantes, France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.Recruiting
Paris, France
Hopital NeckerRecruiting
Paris, France
Policlinico S.Orsola-MalpighiRecruiting
Bologna, Emilia-Romagna, Italy
Humanitas GavazzeniRecruiting
Bergamo, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)Recruiting
Milan, Lombardy, Italy
SC Ematologia, AO SS. Antonio e Biagio e C. ArrigoRecruiting
Alessandria, Piedmont, Italy
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista MolinetteRecruiting
Turin, Piedmont, Italy
Auxilio Mutuo Cancer CenterRecruiting
San Juan, Puerto Rico
Chungnam National University HospitalWithdrawn
Daejeon, South Korea
Severance Hospital, Yonsei University Health SystemActive Not Recruiting
Seoul, South Korea
Seoul National University HospitalActive Not Recruiting
Seoul, South Korea
Asan Medical CenterActive Not Recruiting
Seoul, South Korea
Samsung Medical CenterActive Not Recruiting
Seoul, South Korea
Hospital Universitario Puerta del MarRecruiting
Cadiz, Cadiz, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)Recruiting
A Coruña, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital General Universitario J.M Morales MeseguerRecruiting
Murcia, Spain
Skånes University Hospital, Skånes Department of OnclologyRecruiting
Lund, Sweden
Akademiska sjukhuset, OnkologklinikenRecruiting
Uppsala, Sweden
National Taiwan Universtiy HospitalRecruiting
Taipei, Taiwan
Chang Gung Medical Foundation - LinkouRecruiting
Taoyuan District, Taiwan
NHS Greater Glasgow and ClydeRecruiting
Glasgow, United Kingdom
Lincolnshire County HospitalRecruiting
Lincoln, United Kingdom
University College London HospitalRecruiting
London, United Kingdom
Christie Hospital Nhs TrustRecruiting
Manchester, United Kingdom
Oxford Churchill HospitalRecruiting
Oxford, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom