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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

424

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

June 30, 2029

Study Completion Date

August 31, 2029

Conditions
Relapsed/Refractory Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaRichter's SyndromeTreatment-naïve High Risk Chronic Lymphocytic Leukemia
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.

Trial Locations (87)

2100

RECRUITING

Rigshospitalet, Copenhagen

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

RECRUITING

UZ Leuven, Leuven

3004

RECRUITING

Alfred Health, Melbourne

4000

RECRUITING

Roskilde Sygehus, Roskilde

5000

RECRUITING

Odense University Hospital, Odense

5042

RECRUITING

Flinders Medical Centre, Bedford Park

7100

RECRUITING

Vejle Sygehus, Vejle

8000

RECRUITING

AZ Sint-Jan, Bruges

RECRUITING

Århus University Hospital, Aarhus

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

9100

RECRUITING

Aalborg University Hospital, Aalborg

10032

RECRUITING

Columbia University Herbert Irving Comprehensive Cancer Center, New York

10060

RECRUITING

Istituto di Candiolo, Torino

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10126

RECRUITING

AOU Città della Salute e della Scienza di Torino, Torino

11043

RECRUITING

Northwell Health Cancer Institute, Lake Success

19104

RECRUITING

University of Pennsylvania School of medicine, Philadelphia

20132

RECRUITING

Ospedale San Raffaele, Milan

20892

RECRUITING

National Institutes of Health, Bethesda

24105

RECRUITING

Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum, Kiel

27708

RECRUITING

Duke University Medical Center, Durham

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28040

RECRUITING

Hospital Universitario Fundacion Jiménez Díaz, Madrid

28100

RECRUITING

Ospedale Maggiore di Novara, Novara

33024

RECRUITING

Memorial Healthcare System, Pembroke Pines

33140

RECRUITING

Mount Sinai Comprehensive Cancer Center, Miami Beach

33404

RECRUITING

CHU Hôpital Haut-Lévêque Bordeaux, Pessac

34090

RECRUITING

CHU de Montpellier Hôpital Saint Eloi, Montpellier

35233

RECRUITING

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

43210

RECRUITING

The Ohio State University Comprehensive Cancer Center, Columbus

44000

RECRUITING

Hôpital Privé du Confluent, Nantes

44124

RECRUITING

AOU Arcispedale Sant'Anna, Ferrara

45221

NOT_YET_RECRUITING

University of Cincinnati, Cincinnati

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

47014

RECRUITING

IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST, Meldola

48190

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

48202

RECRUITING

Henry Ford Medical Group, Detroit

50937

RECRUITING

Universitaetsklinikum Koeln, Cologne

54500

RECRUITING

CHU Hôpital de Brabois Nancy, Vandœuvre-lès-Nancy

63000

RECRUITING

CHU Clermont Ferrand, Clermont-Ferrand

75010

RECRUITING

Hôpital Saint-Louis, Paris

75013

RECRUITING

Hôpital Universitaire Pitié-Salpêtrière, Paris

75390

RECRUITING

The University of Texas Southwestern Medical Centre, Dallas

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

89070

RECRUITING

Universitaetsklinikum Ulm, Ulm

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

90095

RECRUITING

David Geffen School of Medicine, Los Angeles

91010

RECRUITING

City of Hope National Medical Center, Duarte

94305

RECRUITING

Stanford Cancer Center, Palo Alto

95817

RECRUITING

University of California Davis Medical Center Sacramento, California City

98109

RECRUITING

Fred Hutchinson Cancer Research Center, Seattle

4941492

RECRUITING

Rabin Medical Center-Beilinson Campus, Petah Tikva

02114

RECRUITING

Massachusetts General Hospital, Boston

07601

RECRUITING

Hackensack Meridian Hospital, Hackensack

Unknown

RECRUITING

St. George Hospital, Kogarah

RECRUITING

Barwon Health, Geelong

RECRUITING

Fakultni Nemocnice Ostrava, Ostrava

RECRUITING

Bnai Zion Medical Center, Haifa

RECRUITING

Hadassah University Hospital - Ein Kerem, Jerusalem

RECRUITING

Chaim Sheba Medical Center, Ramat Gan

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia

RECRUITING

Pratia Medical Center Katowice (Centrum Medyczne Pratia Katowice), Katowice

RECRUITING

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

RECRUITING

Aidport sp z o.o., Skorzewo

RECRUITING

ICO Badalona - Hospital Universitario Germans Trias Pujol, Badalona

RECRUITING

AOC Arcispedale Saint'Anna, Coaña

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

RECRUITING

Hospital Universitario Virgen Macarena, Seville

WITHDRAWN

Nottingham University Hospitals City Campus, Nottingham

WITHDRAWN

St. James s University Hospital, Leeds

128 08

RECRUITING

Vseobecna Fakultni Nemocnice, Prague

500 05

RECRUITING

Fakultni nemocnice Hradec Kralove, Hradec Králové

625 00

RECRUITING

Fakultni nemocnice Brno, Brno

779 00

RECRUITING

Fakultni nemocnice Olomouc, Olomouc

00136

RECRUITING

IRCCS Policlinico Universitario Agostino Gemelli, Rome

00161

RECRUITING

AOU Policlinico Sant'Orsola Malpighi IRCCS, Bologna

RECRUITING

AOU Policlinico Umberto I, Roma

6229 HX

RECRUITING

Maastricht University Medical Center, Maastricht

3318 AT

RECRUITING

Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht

1105 AZ

RECRUITING

Amsterdam UMC, Amsterdam

9713 GZ

RECRUITING

Universitair Medisch Centrum Groningen, Groningen

3584 CX

RECRUITING

Universitair Medisch Centrum Utrecht, Utrecht

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

TR1 3LJ

WITHDRAWN

Royal Cornwall Hospital, Truro

EC1A 7BE

WITHDRAWN

Barts Hospital, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

Genmab

INDUSTRY