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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06084936•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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+16 more criteria

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

Key Dates

Start Date

October 22, 2023

Primary Completion Date

August 31, 2027

Completion Date

March 31, 2028

Last Updated

March 3, 2026

Enrollment

182

ESTIMATED participants

Conditions

Lymphoma

Interventions

Obinutuzumab

DRUG

Glofitamab

DRUG

Rituximab

DRUG

Bendamustine

DRUG

Lenalidomide

DRUG

Tocilizumab

DRUG

Contacts

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

CONTACT

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

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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RECRUITINGPHASE2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

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