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NCT06084936PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

10/22/2023

Completion Date

3/31/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Obinutuzumab

DRUG

Glofitamab

DRUG

Rituximab

DRUG

Bendamustine

DRUG

Lenalidomide

DRUG

Tocilizumab

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Conditions

Lymphoma

Locations

Alta Bates Summit Medical Center

Berkeley, California 94704

United States

City of Hope Cancer Center

Duarte, California 91010

United States

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

Santa Monica, California 90404-2023

United States

Yale Cancer Center

New Haven, Connecticut 06520

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

University of Miami

Coral Gables, Florida 33146

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

St. Luke's Hospital

Chesterfield, Missouri 63017

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Hematology Oncology Associates of Central New York

East Syracuse, New York 13057

United States

University of Rochester

Rochester, New York 14642

United States

Medical University of S. Carolina

Charleston, South Carolina 29425

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Renovatio Clinical - El Paso

El Paso, Texas 79915

United States

Renovatio Clinical

The Woodlands, Texas 77380

United States

University of Virginia

Charlottesville, Virginia 22906

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Calvary Mater Newcastle

Waratah, New South Wales 2298

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Epworth Hospital

Richmond, Victoria 3121

Australia

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia 41253-190

Brazil

ICTR Curitiba

Curitiba, Paraná 80510-130

Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul 90110-000

Brazil

Hospital Paulistano

São Paulo, São Paulo 01321-000

Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo 01327-001

Brazil

Hospital A. C. Camargo

São Paulo, São Paulo 01509-010

Brazil

Instituto D'Or Pesquisa e Ensino

São Paulo, São Paulo 04502-001

Brazil

Americas Medical City

Rio de Janeiro, 22775-001

Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, 01321-00

Brazil

Victoria Hospital - London Health Sciences Centre

London, Ontario N6A 5W9

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

Beijing Tong Ren Hospital, Capital Medical University

Beijing, 100730

China

The First Hospital of Jilin University

Changchun, 130021

China

West China Hospital of Sichuan University

Chengdu, 610041

China

Chongqing Cancer Hospital

Chongqing, 400030

China

Fujian Provincial Cancer Hospital

Fuzhou, 350014

China

Sun yat-sen University Cancer Center

Guangzhou, 510060

China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

The First Affiliated Hospital of China Medical University

Shenyang, 110001

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450003

China

Henan Cancer Hospital

Zhengzhou, 450008

China

Hopital Claude Huriez

Lille, 59037

France

Hopital Saint Eloi

Montpellier, 34295

France

CHU NANTES - Hôtel Dieu

Nantes, 44093

France

INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

Paris, 75005

France

Hopital Necker

Paris, 75743

France

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna 40138

Italy

Humanitas Gavazzeni

Bergamo, Lombardy 24121

Italy

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy 20141

Italy

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

Alessandria, Piedmont 15121

Italy

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

Turin, Piedmont 10126

Italy

Auxilio Mutuo Cancer Center

San Juan, 00918

Puerto Rico

Chungnam National University Hospital

Daejeon, 35015

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 003-722

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 135-710

South Korea

Hospital Universitario Puerta del Mar

Cadiz, Cadiz 11009

Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital General Universitario J.M Morales Meseguer

Murcia, 30008

Spain

Skånes University Hospital, Skånes Department of Onclology

Lund, 221 85

Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, 751 85

Sweden

National Taiwan Universtiy Hospital

Taipei, 100

Taiwan

Chang Gung Medical Foundation - Linkou

Taoyuan, 333

Taiwan

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN

United Kingdom

Lincolnshire County Hospital

Lincoln, LN2 5QY

United Kingdom

University College London Hospital

London, NW1 2PG

United Kingdom

Christie Hospital Nhs Trust

Manchester, M2O 4BX

United Kingdom

Oxford Churchill Hospital

Oxford, OX3 7LE

United Kingdom

Derriford Hospital

Plymouth, PL6 8DH

United Kingdom