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Monoclonal Antibodies
Low Dose Mosunetuzumab for Lymphoma
Phase 2
Recruiting
Led By Ajay Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior systemic therapy (eligible histologies include Follicular lymphoma (grade 1-2 or 3A), Marginal zone lymphoma, Ann Arbor stage II-IV disease)
Low-tumor burden disease as defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria
Must not have
Autoimmune disease requiring active therapy
History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at initiation of study treatment to disease progression, up to 5 years
Awards & highlights
Summary
"This trial is testing a drug called mosunetuzumab on patients with slow-growing B-cell lymphoma to see if it is safe, what side effects it may have, and how well it
Who is the study for?
This trial is for patients with slow-growing B-cell lymphomas, such as Marginal Zone Lymphoma and Follicular Lymphoma. Participants should meet specific health criteria to be eligible.
What is being tested?
The trial is testing the safety and effectiveness of a monoclonal antibody called Mosunetuzumab in treating indolent B-cell lymphoma. It includes tests like CT scans, MRIs, PET scans, and biospecimen collection.
What are the potential side effects?
Possible side effects of Mosunetuzumab may include reactions at the infusion site, fever, fatigue, weakness, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of slow-growing B-cell lymphoma and haven't had treatment yet.
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My cancer is considered to be at an early or controlled stage.
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I am able to get out of my bed or chair and move around.
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My cancer can be measured by scans and shows up on PET scans.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving treatment for an autoimmune disease.
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I have a history of HLH or MAS.
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I do not have any active and uncontrolled infections.
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I am HIV positive.
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I haven't taken any monoclonal antibody medicine in the last 4 weeks.
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I have had another type of cancer that might interfere with this study's requirements.
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I am taking high doses of corticosteroids.
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I have had an organ transplant.
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I have received treatment for lymphoma before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at initiation of study treatment to disease progression, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at initiation of study treatment to disease progression, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response (OR)
Secondary outcome measures
Incidence of adverse events (AE's)
Incidence of grade 3 or greater cytokine release syndrome (CRS)
Progression free survival (PFS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mosunetuzumab)Experimental Treatment6 Interventions
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Mosunetuzumab
2019
Completed Phase 2
~140
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,486 Total Patients Enrolled
Ajay GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
15 Previous Clinical Trials
533 Total Patients Enrolled
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