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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (6 UK sites)
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
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Christie Hospital Nhs Trust
Manchester M2O 4BX, United Kingdom
Oxford Churchill Hospital
Oxford OX3 7LE, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
How to Get in Touch
Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
