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Monoclonal Antibodies
Glofitamab + Lenalidomide for Lymphoma
St Louis, MO
Phase 1
Recruiting
Led By Anita Kumar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. Prior BTKi failure is required
Presence of evaluable disease
Must not have
Any life-threatening illness, medical condition, or organ system dysfunction
Major surgery within 4 weeks prior to planned start of study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is trying to determine if using a combination of glofitamab and lenalidomide can effectively treat people with Mantle Cell Lymphoma that has come back or is not responding
See full description
Who is the study for?
This trial is for people with Mantle Cell Lymphoma that has come back or didn't respond to previous treatments. The specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage of the disease.Check my eligibility
What is being tested?
The study is testing if combining two drugs, Glofitamab and Lenalidomide, can effectively treat Mantle Cell Lymphoma. It might also involve Obinutuzumab as part of the treatment regimen.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer treatments like Glofitamab and Lenalidomide include fatigue, nausea, risk of infection due to low blood cell counts, rash or other skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had treatment for mantle cell lymphoma and it included a BTK inhibitor which did not work.
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My cancer can be measured or observed.
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My cancer cells show CD20 according to my hospital's tests.
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I am able to get out of my bed or chair and move around.
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My diagnosis is mantle cell lymphoma, confirmed by WHO guidelines.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe illnesses or organ problems.
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I have not had major surgery in the last 4 weeks.
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I have not had radiotherapy in the week before starting the study treatment.
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I have been treated with lenalidomide or similar drugs before.
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I have a history of blood clots or a condition that increases my risk for clots.
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I have taken drugs that weaken my immune system.
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I haven't taken corticosteroids in the last 2 weeks.
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I received a CART infusion less than 30 days before starting the treatment cycle.
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I do not have any active infections when joining the study.
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My lymphoma has spread to my brain or spinal cord.
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I have experienced significant side effects from previous cancer treatments.
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I have been treated with a therapy targeting both CD20 and CD3.
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I do not have any uncontrolled serious illnesses.
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I do not have a significant history of liver disease or uncontrolled alcohol use.
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I have been diagnosed with progressive multifocal leukoencephalopathy.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants who successfully receive glofitamab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Mantle Cell LymphomaExperimental Treatment3 Interventions
Participants will be diagnosed with relapsed, refractory (R/R) mantle cell lymphoma (MCL) with prior BTK inhibitor (BTKi) failure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3640
Glofitamab
2021
Completed Phase 1
~170
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Closest Location:Washington University (Data Collection Only)· St Louis, MO· 396 miles
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,995 Previous Clinical Trials
602,565 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,576 Previous Clinical Trials
570,928 Total Patients Enrolled
Anita Kumar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
729 Total Patients Enrolled