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NCT04623541 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
A Phase 1 study of Small Lymphocytic Lymphoma and Richter's Syndrome, sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT04623541 is a Phase 1 study of Small Lymphocytic Lymphoma and Richter's Syndrome that is active but no longer recruiting, run by Genmab. The registered enrollment target is 195 participants, roughly in line with the 190-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target. The trial reports 20 study locations across 11 states.
The verdict
NCT04623541, a Phase 1 study of Small Lymphocytic Lymphoma and Richter's Syndrome, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as: * Monotherapy, or * Combination therapy: * epcoritamab + venetoclax * epcoritamab + pirtobrutinib In Non-United States (US) Participants Only: Treatment-naïve (TN) high risk (HR) (CLL): • epcoritamab + pirtobrutinib Combination therapy for Richter's Syndrome (RS): * epcoritamab + lenalidomide * epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine \[Oncovin®\] and prednisone). The study includes participants with R/R or TN HR CLL (non-US participants only)/small lymphocytic lymphoma (SLL) and participants with RS. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: * Study duration will be up to 5 years after the last participant's first treatment in the trial. * The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned. * The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo.
Conditions Studied
Interventions
- DRUG Venetoclax
- BIOLOGICAL Epcoritamab
- DRUG rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
Study Locations (20)
California
- University of California Davis Medical Center Sacramento - California City
- City of Hope National Medical Center - Duarte
- Cedars-Sinai Medical Center - Los Angeles
- David Geffen School of Medicine - Los Angeles
- Stanford Cancer Center - Palo Alto
New York
- Northwell Health Cancer Institute - Lake Success
- Columbia University Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Memorial Healthcare System - Pembroke Pines
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Henry Ford Medical Group - Detroit
Ohio
- University of Cincinnati - Cincinnati
- The Ohio State University Comprehensive Cancer Center - Columbus
Alabama
- O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham - Birmingham
Maryland
- National Institutes of Health - Bethesda
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04623541
The ClinicalTrials.gov registry entry for NCT04623541 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 190-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target. The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04623541 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04623541 about?
NCT04623541 is a clinical study titled "Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome". The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as: * Monotherapy, or * Combination therapy: * epco...
What is the current status of trial NCT04623541?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 195 participants. The study started on 2020-11-25. Estimated completion is 2028-02.
What conditions does trial NCT04623541 study?
This clinical trial studies the following conditions: Small Lymphocytic Lymphoma, Richter's Syndrome, Relapsed/Refractory Chronic Lymphocytic Leukemia, Treatment-naïve High Risk Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT04623541?
The interventions under investigation include: Venetoclax (DRUG), Epcoritamab (BIOLOGICAL), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (DRUG).
Who is sponsoring clinical trial NCT04623541?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04623541 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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