Comparing Obinutuzumab with Rituximab for lymphoma
Official title: A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
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
Interventions
Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
Rituximab
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
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Canadian Sites (3)
Victoria Hospital - London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Negative HIV test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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
- +Adequate hematological function
Exclusion
- −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
- −Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- −Leukemic, non-nodal MCL
- −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 protocolProtocolThe detailed plan a study must follow.Read more → or interpretation of results
- −Significant or extensive cardiovascular disease
- −Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or any major episode of infection within 4 weeks prior to the first study treatment
- −Suspected or latent tuberculosis
- −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 eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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
- −EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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
- −Clinically significant history of cirrhotic liver disease
- −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
- −Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Obinutuzumab, Glofitamab, Rituximab, Bendamustine, and 2 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 182 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause (up to approximately 24 months).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free survival (PFS) — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause (up to approximately 24 months).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06084936 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ObinutuzumabDrug
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GlofitamabDrug
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 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).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BendamustineDrug
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LenalidomideDrug
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TocilizumabDrug
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause (up to approximately 24 months).
The study as a whole is currently expected to finish around 2028-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 182 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: London, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; East Syracuse, New York, United States; Rochester, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (4)
University of Michigan Health System
Ann Arbor, Michigan, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Hospital Cancer Center
Stony Brook, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.