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Monoclonal Antibodies
Epcoritamab for Non-Hodgkin's Lymphoma
Phase 2
Waitlist Available
Led By Gottfried Von Keudell, MD, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.
* Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \>1.0 cm and Deauville ≥ 4 seen on baseline PET/CT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment. The name of the study drug in this research study is: -Epcoritamab (a type of antibody)
Eligible Conditions
- Non-Hodgkin's Lymphoma
- Lymphoma
- Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response Rate (CRR)
Secondary study objectives
Grade 4-5 Treatment-related Toxicity Rate
Median Duration of Complete Response
Median Duration of Response (DOR)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: EpcoritamabExperimental Treatment1 Intervention
35 participants will be enrolled and will complete study procedures as follows:
* Baseline visit with imaging (CT, MRI or PET scan) and bone marrow biopsy.
* Imaging after Cycles 3 and 6 only.
* Cycles 1-3:
--Days 1, 8, 15 and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily
* Cycles 4-9:
--Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily
* Cycles 10-12:
--Day 1 of 28 day cycles: Predetermined dose of Epcoritamab 1x daily
* End of Treatment visit with imaging and bone marrow biopsy.
* Follow up: every 3 months for 2 years or until disease worsens.
* Off study visit with imaging.
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Who is running the clinical trial?
GenmabIndustry Sponsor
65 Previous Clinical Trials
13,080 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
847 Previous Clinical Trials
13,012,518 Total Patients Enrolled
Gottfried Von Keudell, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
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