Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT04623541
- Run by
- Genmab
- People needed
- 194
- Starts
- 2020-11-25
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Aidport sp z o.o. — Skorzewo, Poland
- AOC Arcispedale Saint'Anna — Coaña, Ferarra, Spain
- Hospital Clinico Universitario de Valencia — Valencia, València, Spain
- Hospital Clinic de Barcelona — Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- Hospital Universitario Ramón y Cajal — Madrid, Spain
- Hospital Universitario Fundacion Jiménez Díaz — Madrid, Spain
- Hospital Universitario Virgen Macarena — Seville, Spain
- IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST — Meldola, Forli - Cesena, Italy
- IRCCS Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
- AOU Policlinico Sant'Orsola Malpighi IRCCS — Bologna, Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) — Brescia, Italy
- Ospedale San Raffaele — Milan, Italy
- Ospedale Maggiore di Novara — Novara, Italy
- AOU Policlinico Umberto I — Roma, Italy
- AOU Città della Salute e della Scienza di Torino — Torino, Italy
- CHU Hôpital de Brabois Nancy — Vandœuvre-lès-Nancy, Meurthe Et Moselle, France
- Hôpital Privé du Confluent — Nantes, Pays de la Loire Region, France
- CHU Clermont Ferrand — Clermont-Ferrand, Puy De Dome, France
- Hôpital Saint-Louis — Paris, France
- Hôpital Universitaire Pitié-Salpêtrière — Paris, France
- Universitaetsklinikum Koeln — Cologne, Germany
- Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum — Kiel, Germany
- Bnai Zion Medical Center — Haifa, Israel
- Pratia Malopolskie Medical Center Krakow (Pratia Małopolskie Centrum Medyczne Krakow) — Krakow, Poland
Full record on ClinicalTrials.gov
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