Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Phase 1

Not yet recruiting

• Conditions: Leukemia, Chronic Lymphocytic; Richter Syndrome
• Interventions: Drug: epcoritamab

• Registration Number: NCT06676033
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

This correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in GCT3013-03 trial sponsored by Genmab at NIH. Samples will be collected before and at multiple time points during treatment with epcoritamab. Nation...

Detailed Description

Study Description:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-06
• Status Verified: 2024-11-25
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Study Start: 2024-12-25
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epcoritamab	epcoritamab	Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.

Primary Outcome Measures

Name	Time	Method
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow	25 days (Cycle 1 Day 25)

Secondary Outcome Measures

Name	Time	Method
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood	167 Days (Cycle 7 Day 1)
DNA sequencing of tumor cells	167 Days (Cycle 7 Day 1)

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States