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Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma

This study is looking at a new treatment called glofitamab for people with mantle cell lymphoma (MCL) that has come back (relapsed) or didn't respond to previous treatments (refractory). Glofitamab works by targeting two different things at once (BISPECIFIC mechanism). You would receive glofitamab after two doses of obinutuzumab. Researchers want to see if glofitamab alone works better than other standard treatments, which are rituximab combined with either bendamustine or lenalidomide. To join, you must be at least 18 years old, have MCL that has relapsed or is refractory, and have a life expectancy of at least 12 weeks. The main goal is to see how long people live without their cancer getting worse (progression-free survival), measured for up to about 24 months. The study aims to enroll 182 participants.

Study design
This is an interventional study comparing glofitamab alone to an investigator's choice of two other drug combinations. It plans to enroll 182 participants.
What's involved
You would receive two pretreatments of obinutuzumab, followed by glofitamab for 12 cycles (each 21 days long). If in the comparison group, you would receive rituximab plus bendamustine for 6 cycles, or rituximab plus lenalidomide until disease progression.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured from randomization to disease progression or death, for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06084936

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~182 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:ObinutuzumabGlofitamabRituximabBendamustineLenalidomideTocilizumab

At a glance

Recruiting sites
68 of 82 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)

Conditions

Lymphoma

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Mantle Cell LymphomaCellular proto-oncogene BCL1t(11;14)

NCT06084936

Where you'd take part

This study runs at 82 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Turin, Piedmont, Italyno site contact published

    Recruiting

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, Swedenno site contact published

    Recruiting

  • Americas Medical City

    Rio de Janeiro, Brazilno site contact published

    Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, Puerto Ricono site contact published

    Recruiting

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, Chinano site contact published

    Recruiting

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, Brazilno site contact published

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, Australiano site contact published

    Recruiting

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, Taiwanno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-free survival (PFS)From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)