Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04623541
PHASE1/PHASE2

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Sponsor: Genmab

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2020-11-25

Completion Date

2028-02

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days, (except Cycle 1 for high-dose cohorts = 35 days).

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 21 days and 28 days.

DRUG

rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

R-CHOP will be administered intravenously (prednisone may be administered orally) in cycles of 21 days.

DRUG

Venetoclax

Venetoclax tablets will be administered orally once daily during the 5-week ramp up period in cycles of 28 or 35 days each.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

DRUG

Lenalidomide

Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

DRUG

Pirtobrutinib

Pirtobrutinib tablets will be administered in cycles of 28 days.

BIOLOGICAL

Epcoritamab

Epcoritamab will be administered subcutaneously in cycles of 28 days.

Locations (83)

O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California Davis Medical Center Sacramento

California City, California, United States

City of Hope National Medical Center

Duarte, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

David Geffen School of Medicine

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Memorial Healthcare System

Pembroke Pines, Florida, United States

National Institutes of Health

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Medical Group

Detroit, Michigan, United States

Hackensack Meridian Hospital

Hackensack, New Jersey, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania School of medicine

Philadelphia, Pennsylvania, United States

The University of Texas Southwestern Medical Centre

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

St. George Hospital

Kogarah, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Barwon Health

Geelong, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

AZ Sint-Jan

Bruges, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Fakultni nemocnice Brno

Brno, Czechia, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia, Czechia

Vseobecna Fakultni Nemocnice

Prague, Nové Město, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Nový Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava, Poruba, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Aalborg University Hospital

Aalborg, Denmark

Århus University Hospital

Aarhus, Denmark

Odense University Hospital

Odense, Denmark

Roskilde Sygehus

Roskilde, Denmark

Vejle Sygehus

Vejle, Denmark

CHU de Montpellier Hôpital Saint Eloi

Montpellier, Cedex 5, France

CHU Hôpital Haut-Lévêque Bordeaux

Pessac, Gironde, France

CHU Hôpital de Brabois Nancy

Vandœuvre-lès-Nancy, Meurthe et Moselle, France

Hôpital Saint-Louis

Paris, Paris, France

Hôpital Universitaire Pitié-Salpêtrière

Paris, Paris, France

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, France

CHU Clermont Ferrand

Clermont-Ferrand, Puy de Dome, France

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum

Kiel, Germany

Bnai Zion Medical Center

Haifa, Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

AOU Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Bologna, Italy

Istituto di Candiolo

Torino, Candiolo, Italy

AOU Arcispedale Sant'Anna

Ferrara, Cona, Italy

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 Umberto I

Roma, Roma, Italy

AOU Città della Salute e della Scienza di Torino

Torino, Torino, 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

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Albert Schweitzer Ziekenhuis, Dordwijk

Dordrecht, South Holland, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Utrecht, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Pratia Medical Center Katowice (Centrum Medyczne Pratia Katowice)

Katowice, Poland, Poland

Pratia Malopolskie Medical Center Krakow (Pratia Małopolskie Centrum Medyczne Krakow)

Krakow, Poland, Poland

Aidport sp z o.o.

Skorzewo, Poland, Poland

ICO Badalona - Hospital Universitario Germans Trias Pujol

Badalona, Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

AOC Arcispedale Saint'Anna

Coaña, Ferarra, Spain

Hospital Universitario Fundacion Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Clinico Universitario de Valencia

Valencia, València, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain