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Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Sponsor: Genmab
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
Conditions
Interventions
Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 28 days, (except Cycle 1 for high-dose cohorts = 35 days).
Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 21 days and 28 days.
rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
R-CHOP will be administered intravenously (prednisone may be administered orally) in cycles of 21 days.
Venetoclax
Venetoclax tablets will be administered orally once daily during the 5-week ramp up period in cycles of 28 or 35 days each.
Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 28 days.
Lenalidomide
Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days.
Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 28 days.
Pirtobrutinib
Pirtobrutinib tablets will be administered in cycles of 28 days.
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