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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT06084936

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Obinutuzumab (drug), Glofitamab (drug), Rituximab (drug), Bendamustine (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
Obinutuzumab — drug: Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1 · Glofitamab — drug: Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days). · Rituximab — drug: 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). · Bendamustine — drug: Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days). · Lenalidomide — drug: Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression. · Tocilizumab — drug: Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
182
Started
2023-10-22
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for lymphoma
  • • Phase3 - 182 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lymphoma

Where?

  • • Glasgow - NHS Greater Glasgow and Clyde
  • • Lincoln - Lincolnshire County Hospital
  • • London - University College London Hospital
  • • Manchester - Christie Hospital Nhs Trust
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This 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).

Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

related fusionCD20CD3

What the study is looking for

  • ✓Life expectancy at least 12 weeks
  • ✓Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)...
  • ✓Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or...
  • ✓At least 1 line of prior treatment that goes through your whole body including a BTK inhibitor and additional treatment that goes through your whole body option
  • ✓Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment

Who cannot take part

  • ✗Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final...
  • ✗Leukemic, non-nodal MCL
  • ✗History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant...
  • ✗safety concern to obinutuzumab or rituximab, and either bendamustine or lenalidomide
  • ✗Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
See the full criteria
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

Where Is This Study? (6 UK sites)

NHS Greater Glasgow and Clyde

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Lincolnshire County Hospital

Lincoln LN2 5QY, United Kingdom

Recruiting

University College London Hospital

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Christie Hospital Nhs Trust

Manchester M2O 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Oxford Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Derriford Hospital

Plymouth PL6 8DH, United Kingdom

Recruiting

How to Get in Touch

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

Sponsor contact

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10