RecruitingPhase IIIEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Przewidywany czas życia co najmniej 12 tygodni.
  • Potwierdzony chłoniak z komórek płaszcza (MCL) z określonymi cechami w ciągu ostatnich 12 miesięcy.
  • Choroba nawróciła lub nie zareagowała na poprzednie leczenie.
  • Pacjent otrzymał co najmniej jedną linię leczenia systemowego, w tym lek z grupy inhibitorów BTK, oraz inną terapię systemową.
  • Istnieje możliwość pobrania próbki tkanki guza do badań.
  • Widoczna na badaniu tomografii komputerowej zmiana (węzeł chłonny lub inna tkanka) o odpowiednich rozmiarach.
  • Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (skala ECOG 0, 1 lub 2).

✗ Disqualifies

  • Ciąża, karmienie piersią lub zamiar zajścia w ciążę w trakcie badania lub po jego zakończeniu.
  • Chłoniak z komórek płaszcza w postaci białaczkowej (bez obecności węzłów chłonnych).
  • Wcześniejsze ciężkie reakcje alergiczne na leki podobne do tych stosowanych w badaniu.
  • Przeciwwskazania do stosowania niektórych leków badanych w tym protokole.
  • Wcześniejsze leczenie lekiem glofitamab lub podobnymi lekami.
  • Wcześniejsze leczenie terapią komórkami CAR-T.
  • Przyjmowanie innych leków na raka lub inhibitorów BTK w ciągu ostatnich 2 tygodni przed rozpoczęciem leczenia w badaniu.
  • Chłoniak obejmujący ośrodkowy układ nerwowy (mózg, rdzeń kręgowy).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (77)

Alta Bates Summit Medical Center

Berkeley, United States

City of Hope Cancer Center

Duarte, United States

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

Santa Monica, United States

Yale Cancer Center

New Haven, United States

Georgetown University

Washington D.C., United States

University of Miami

Coral Gables, United States

Indiana University

Indianapolis, United States

University of Michigan Health System

Ann Arbor, United States

St. Luke's Hospital

Chesterfield, United States

Renown Regional Medical Center

Reno, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, United States

Hematology Oncology Associates of Central New York

East Syracuse, United States

University of Rochester

Rochester, United States

Medical University of S. Carolina

Charleston, United States

Avera Cancer Institute

Sioux Falls, United States

Renovatio Clinical - El Paso

El Paso, United States

Renovatio Clinical

The Woodlands, United States

University of Virginia

Charlottesville, United States

West Virginia University

Morgantown, United States

Calvary Mater Newcastle

Waratah, Australia

Royal Adelaide Hospital

Adelaide, Australia

Epworth Hospital

Richmond, Australia

Hospital Sao Rafael - HSR

Salvador, Brazil

ICTR Curitiba

Curitiba, Brazil

Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Paulistano

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Hospital A. C. Camargo

São Paulo, Brazil

Instituto D'Or Pesquisa e Ensino

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, Canada

The Ottawa Hospital - General Campus

Ottawa, Canada

Princess Margaret Cancer Center

Toronto, 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, Italy

Humanitas Gavazzeni

Bergamo, Italy

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Italy

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

Alessandria, Italy

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

Turin, 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, 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, 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

Trial contact

Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.