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RECRUITING

NCT06084936

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2023-10-22

Completion Date

2028-03-31

Last Updated

2026-04-02

Healthy Volunteers

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.

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

Locations (75)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (75)