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

NCT06084936 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GO43878
• Study Type: interventional
• Target: 182
• Locations: 13 countries
• Sites: 76

Brief 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).

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)

Secondary Outcomes (16)

• Complete response (CR) rate

  Up to approximately 24 months

• Objective response rate (ORR)

  Up to approximately 24 months

• Overall survival (OS)

  From randomization to death from any cause (up to approximately 24 months)

• Time to deterioration in physical functioning/fatigue

  From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)

• Investigator-assessed PFS

  From randomization to disease progression or death from any cause (up to approximately 24 months)

Study Arms (2)

Glofitamab monotherapy

EXPERIMENTAL

Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).

Drug: Obinutuzumab; Drug: Glofitamab; Drug: Tocilizumab

BR or R-Len

ACTIVE COMPARATOR

Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.

Drug: Rituximab; Drug: Bendamustine; Drug: Lenalidomide; Drug: Tocilizumab

Interventions

Obinutuzumab DRUG

Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1

Glofitamab monotherapy

Glofitamab DRUG

Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).

Glofitamab monotherapy

Rituximab DRUG

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).

BR or R-Len

Bendamustine DRUG

Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).

BR or R-Len

Lenalidomide DRUG

Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.

BR or R-Len

Tocilizumab DRUG

Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.

BR or R-Len; Glofitamab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (76)

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

WITHDRAWN

City of Hope Cancer Center

Duarte, California, 91010, United States

RECRUITING

University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

Santa Monica, California, 90404-2023, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

WITHDRAWN

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Medical University of S. Carolina

Charleston, South Carolina, 29425, United States

WITHDRAWN

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

WITHDRAWN

Renovatio Clinical - El Paso

El Paso, Texas, 79915, United States

RECRUITING

Renovatio Clinical

The Woodlands, Texas, 77380, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22906, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Epworth Hospital

Richmond, Victoria, 3121, Australia

RECRUITING

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

WITHDRAWN

ICTR Curitiba

Curitiba, Paraná, 80510-130, Brazil

RECRUITING

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

RECRUITING

Hospital Paulistano

São Paulo, São Paulo, 01321-000, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01327-001, Brazil

RECRUITING

Hospital A. C. Camargo

São Paulo, São Paulo, 01509-010, Brazil

RECRUITING

Instituto D'Or Pesquisa e Ensino

São Paulo, São Paulo, 04502-001, Brazil

RECRUITING

Americas Medical City

Rio de Janeiro, 22775-001, Brazil

RECRUITING

Beneficencia Portuguesa de Sao Paulo

São Paulo, 01321-00, Brazil

RECRUITING

Victoria Hospital - London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Beijing Tong Ren Hospital, Capital Medical University

Beijing, 100730, China

RECRUITING

The First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, 610041, China

ACTIVE NOT RECRUITING

Chongqing Cancer Hospital

Chongqing, 400030, China

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, 350014, China

RECRUITING

Sun yat-sen University Cancer Center

Guangzhou, 510060, China

ACTIVE NOT RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, 110001, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035, China

COMPLETED

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450003, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, 450008, China

RECRUITING

Hopital Claude Huriez

Lille, 59037, France

RECRUITING

Hopital Saint Eloi

Montpellier, 34295, France

RECRUITING

CHU NANTES - Hôtel Dieu

Nantes, 44093, France

RECRUITING

INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

Paris, 75005, France

RECRUITING

Hopital Necker

Paris, 75743, France

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Humanitas Gavazzeni

Bergamo, Lombardy, 24121, Italy

RECRUITING

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

RECRUITING

SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo

Alessandria, Piedmont, 15121, Italy

RECRUITING

A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette

Turin, Piedmont, 10126, Italy

RECRUITING

Auxilio Mutuo Cancer Center

San Juan, 00918, Puerto Rico

RECRUITING

Chungnam National University Hospital

Daejeon, 35015, South Korea

WITHDRAWN

Severance Hospital, Yonsei University Health System

Seoul, 003-722, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

COMPLETED

Asan Medical Center

Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

ACTIVE NOT RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, 11009, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario J.M Morales Meseguer

Murcia, 30008, Spain

RECRUITING

Skånes University Hospital, Skånes Department of Onclology

Lund, 221 85, Sweden

RECRUITING

Akademiska sjukhuset, Onkologkliniken

Uppsala, 751 85, Sweden

RECRUITING

National Taiwan Universtiy Hospital

Taipei, 100, Taiwan

RECRUITING

Chang Gung Medical Foundation - Linkou

Taoyuan, 333, Taiwan

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN, United Kingdom

RECRUITING

Lincolnshire County Hospital

Lincoln, LN2 5QY, United Kingdom

RECRUITING

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

Christie Hospital Nhs Trust

Manchester, M2O 4BX, United Kingdom

RECRUITING

Oxford Churchill Hospital

Oxford, OX3 7LE, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Lymphoma

Interventions

obinutuzumab; glofitamab; Rituximab; Bendamustine Hydrochloride; Lenalidomide; tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO43878 https://forpatients.roche.com/

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 16, 2023
• Study Start: October 22, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); BR (9); US (18); CA (3); AU (3); KR (5); ES (5); GB (6); IT (5); FR (5); PR (1); TW (2); CN (12)