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Monoclonal Antibodies

Glofitamab + Lenalidomide for Lymphoma

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

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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
~3470
Lenalidomide
2005
Completed Phase 3
~2240
Glofitamab
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,284 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,397 Total Patients Enrolled
Anita Kumar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
729 Total Patients Enrolled
~26 spots leftby Jan 2028
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