Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Public ClinicalTrials.gov record NCT04623541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04623541
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 194 participants
Conditions and interventions
Conditions
Interventions
- Epcoritamab Biological
- rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone Drug
- Venetoclax Drug
- Lenalidomide Drug
- Pirtobrutinib Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 24, 2020
- Primary completion
- Nov 30, 2027
- Completion
- Jan 31, 2028
- Last update posted
- Sep 8, 2026
2020 – 2028
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California Davis Medical Center Sacramento | California City | California | 95817 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| David Geffen School of Medicine | Los Angeles | California | 90095 | — |
| Stanford Cancer Center | Palo Alto | California | 94305 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Memorial Healthcare System | Pembroke Pines | Florida | 33024 | — |
| National Institutes of Health | Bethesda | Maryland | 20892 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48190 | — |
| Henry Ford Medical Group | Detroit | Michigan | 48202 | — |
| Hackensack Meridian Hospital | Hackensack | New Jersey | 07601 | — |
| Northwell Health Cancer Institute | Lake Success | New York | 11043 | — |
| Columbia University Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27708 | — |
| University of Cincinnati | Cincinnati | Ohio | 45221 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Pennsylvania School of medicine | Philadelphia | Pennsylvania | 19104 | — |
| The University of Texas Southwestern Medical Centre | Dallas | Texas | 75390 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04623541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04623541 live on ClinicalTrials.gov.