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LymphomaPhase 3GLOBRYTENCT06084936

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

A Phase 3 study testing Obinutuzumab, Glofitamab and Rituximab in people with Lymphoma, run by Hoffmann-La Roche at 83 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Obinutuzumab, Glofitamab and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
83 sitesin 13 countries
Study dates
22 Oct 2023to 31 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Negative HIV test at screening
  • Adequate hematological function

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

83 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

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

888-662-6728

global-roche-genentech-trials@gene.com

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

83 sites in 13 countries

United States25 sites, 21 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Recruiting

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

    Withdrawn

  • Medical University of S. Carolina

    Charleston, South Carolina, 29425

    Withdrawn

  • University of Virginia

    Charlottesville, Virginia, 22906

    Recruiting

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

    Recruiting

  • University of Miami

    Coral Gables, Florida, 33146

    Recruiting

  • City of Hope Cancer Center

    Duarte, California, 91010

    Recruiting

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

    Recruiting

  • Renovatio Clinical - El Paso

    El Paso, Texas, 79915

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Withdrawn

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Recruiting

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

    Santa Monica, California, 90404-2023

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Withdrawn

  • Stony Brook University Hospital Cancer Center

    Stony Brook, New York, 11794

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20007

    Recruiting

  • University of Iowa Health Care

    Waukee, Iowa, 50263

    Recruiting

Other trials in United States

China12 sites, 8 recruiting

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, 100730

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041

    Active, not recruiting

  • Chongqing Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, 350014

    Recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060

    Active, not recruiting

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Active, not recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325035

    Completed

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450003

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Recruiting

Other trials in China

Brazil9 sites, 8 recruiting

  • Ictrials Pesquisa e Desenvolvimento

    Curitiba, Paraná, 80510-130

    Recruiting

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-000

    Recruiting

  • Americas Medical City

    Rio de Janeiro, 22775-001

    Recruiting

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

    Withdrawn

  • Hospital Paulistano

    São Paulo, São Paulo, 01321-000

    Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

    Recruiting

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-010

    Recruiting

  • Instituto D'Or Pesquisa e Ensino

    São Paulo, São Paulo, 04502-001

    Recruiting

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01321-00

    Recruiting

Other trials in Brazil

United Kingdom6 sites, 6 recruiting

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

    Recruiting

  • Lincolnshire County Hospital

    Lincoln, LN2 5QY

    Recruiting

  • University College London Hospital

    London, NW1 2PG

    Recruiting

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX

    Recruiting

  • Oxford Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

  • Derriford Hospital

    Plymouth, PL6 8DH

    Recruiting

Other trials in United Kingdom

France5 sites, 5 recruiting

  • Hopital Claude Huriez

    Lille, 59037

    Recruiting

  • Hopital Saint Eloi

    Montpellier, 34295

    Recruiting

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093

    Recruiting

  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

    Paris, 75005

    Recruiting

  • Hopital Necker

    Paris, 75743

    Recruiting

Other trials in France

Italy5 sites, 5 recruiting

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

    Alessandria, Piedmont, 15121

    Recruiting

  • Humanitas Gavazzeni

    Bergamo, Lombardy, 24121

    Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

    Recruiting

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141

    Recruiting

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

    Turin, Piedmont, 10126

    Recruiting

Other trials in Italy

South Korea5 sites

  • Chungnam National University Hospital

    Daejeon, 35015

    Withdrawn

  • Severance Hospital, Yonsei University Health System

    Seoul, 003-722

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Completed

  • Asan Medical Center

    Seoul, 05505

    Completed

  • Samsung Medical Center

    Seoul, 135-710

    Active, not recruiting

Other trials in South Korea

Spain5 sites, 5 recruiting

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, Cadiz, 11009

    Recruiting

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008

    Recruiting

Other trials in Spain

Australia3 sites, 2 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

  • Epworth Hospital

    Richmond, Victoria, 3121

    Withdrawn

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • Victoria Hospital - London Health Sciences Centre

    London, Ontario, N6A 5W9

    Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Sweden2 sites, 2 recruiting

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 221 85

    Recruiting

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85

    Recruiting

Other trials in Sweden

Taiwan2 sites, 2 recruiting

  • National Taiwan Universtiy Hospital

    Taipei, 100

    Recruiting

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Puerto Rico1 site, 1 recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 00918

    Recruiting

Other trials in Puerto Rico

About this study

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

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
Being tested
Obinutuzumab, Glofitamab, Rituximab, Bendamustine, Lenalidomide
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

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

  • GlofitamabDrug

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

  • RituximabDrug

    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).

  • BendamustineDrug

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

  • LenalidomideDrug

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

  • TocilizumabDrug

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

Study groups in NCT06084936
Study groupRoleWhat they receive
Glofitamab monotherapyExperimentalParticipants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Tocilizumab
BR or R-LenActive comparatorParticipants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Lenalidomide; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

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

Secondary outcomes (16)

  1. Complete response (CR) rate

    Measured: Up to approximately 24 months

  2. Objective response rate (ORR)

    Measured: Up to approximately 24 months

  3. Overall survival (OS)

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

  4. Time to deterioration in physical functioning/fatigue

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

  5. Investigator-assessed PFS

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

  6. Investigator-assessed CR rate

    Measured: Up to approximately 24 months

  7. Investigator-assessed ORR

    Measured: Up to approximately 24 months

  8. Duration of Complete Response (DOCR)

    Measured: From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)

  9. Duration of Response (DOR)

    Measured: From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)

  10. Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale

    Measured: Up to approximately 24 months

  11. Time to deterioration in lymphoma symptoms

    Measured: From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months)

  12. Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS

    Measured: Up to approximately 24 months

  13. Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)

    The EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning and symptoms items are scored on a 4-point scale that ranges from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent."

    Measured: Up to approximately 24 months

  14. Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS

    Measured: Up to approximately 24 months

  15. Serum concentration of glofitamab

    Measured: Up to approximately 24 months

  16. Incidence of anti-drug antibodies (ADAs)

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start22 Oct 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084936
Sponsor's protocol ID
GO43878
Acronym
GLOBRYTE
Status last verified
Oct 2026
First submitted
14 Sep 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obinutuzumab, Glofitamab and Rituximab in people with Lymphoma, run by Hoffmann-La Roche at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, China, Brazil, United Kingdom, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06084936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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