Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

The trial is an open-label, multi-center safety and efficacy trial of epcoritamab in relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia (R/R CLL) and Ritcher's Syndrome (RS). The trial consists of two parts, a dose escalation phase (phase Ib) and an expansion phase (phase II).

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Full Description

The purpose of the dose-escalation phase of the trial is to determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD; if reached) as well as establish the safety profile of epcoritamab monotherapy and epcoritamab + venetoclax in participants with R/R CLL.

The purpose of the expansion phase is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy and epcoritamab + venetoclax at the RP2D for patients with R/R CLL/SLL. Along with this, epcoritamab monotherapy, epcoritamab + lenalidomide and epcoritamab + R-CHOP will be evaluated in patients with RS to assess their efficacy, safety and tolerability profiles.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Evidence of CD20 positivity in a sample representative of the disease at Screening.
Acceptable hematology parameters and organ function based on baseline bloodwork.
For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
For R/R CLL arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.
For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan.
For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
Life expectancy >3 months on standard of care (SOC).
For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy

For RS - lenalidomide combination therapy arm

Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy.
Eligible for treatment with lenalidomide.
Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan

For RS - R-CHOP combination Therapy Arm -

Eligible for treatment with R-CHOP.
For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.

Key Exclusion Criteria

Received prior treatment with a CD3×CD20 bispecific antibody.
Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
Received (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of epcoritamab.
Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
Received vaccination with live vaccines within 28 days.
Clinically significant cardiac disease.
Known current malignancy other than inclusion diagnosis.
Has had major surgery within 4 weeks.
Active hepatitis B virus or active hepatitis C.
Known history of HIV.
For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation.
Received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial and progressed on treatment.
For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

184

Study ID:

NCT04623541

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 58 Locations for this study

See Locations Near You

O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
David Geffen School of Medicine
Los Angeles California, 90095, United States
Stanford Cancer Center
Palo Alto California, 94305, United States
Memorial Healthcare System
Pembroke Pines Florida, 33024, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48190, United States
Henry Ford Medical Group
Detroit Michigan, 48202, United States
Hackensack Meridian Hospital
Hackensack New Jersey, 07601, United States
Northwell Health Cancer Institute
Lake Success New York, 11043, United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
James Cancer Hospital
Columbus Ohio, 43210, United States
University of Pennsylvania School of medicine
Philadelphia Pennsylvania, 19104, United States
The University of Texas Southwestern Medical Centre
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
St. George Hospital
Kogarah New South Wales, , Australia
Barwon Health
Geelong Victoria, , Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Alfred Health
Melbourne Victoria, 3004, Australia
AZ Sint-Jan
Bruges , 8000, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Vseobecna Fakultni Nemocnice
Praha Nové Město, 128 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové Nový Hradec Králové, 500 0, Czechia
Fakultni Nemocnice Ostrava
Ostrava Poruba, , Czechia
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 779 0, Czechia
Rigshospitalet
København Hovedstaden, 2100, Denmark
Aalborg University Hospital
Aalborg , 9100, Denmark
Odense University Hospital
Odense , 5000, Denmark
Roskilde Sygehus
Roskilde , 4000, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Århus University Hospital
Århus , 8000, Denmark
CHU de Montpellier Hôpital Saint Eloi
Montpellier Cedex 5, 34090, France
CHU Hôpital Haut-Lévêque Bordeaux
Pessac Gironde, 33404, France
CHU Hôpital de Brabois Nancy
Vandœuvre-lès-Nancy Meurthe Et Moselle, 54500, France
Hôpital Privé du Confluent
Nantes Pays De La Loire, 44000, France
CHU Clermont Ferrand
Clermont Ferrand cedex Puy De Dome, 63000, France
Hôpital Saint-Louis
Paris , 75010, France
Hôpital Universitaire Pitié-Salpêtrière
Paris , 75013, France
Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum
Kiel , 24105, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Bnai Zion Medical Center
Haifa , , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem , , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva , 49414, Israel
Chaim Sheba Medical Center
Ramat Gan , , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo , , Israel
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola Forli - Cesena, 47014, Italy
IRCCS Policlinico Universitario Agostino Gemelli
Roma Lazio, 00136, Italy
AOU Policlinico Sant'Orsola Malpighi IRCCS
Bologna , 00161, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia , , Italy
Ospedale San Raffaele
Milano , 20132, Italy
Ospedale Maggiore di Novara
Novara , 28100, Italy
AOU Policlinico Umberto I
Roma , 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma , 00168, Italy
Maastricht University Medical Center
Maastricht Limburg, 6229 , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht South Holland, 3318 , Netherlands
Amsterdam UMC
Amsterdam , 1105 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
ICO Badalona - Hospital Universitario Germans Trias Pujol
Badalona Barcelona, , Spain
AOC Arcispedale Saint'Anna
Coaña Ferarra, , Spain
Hospital Clinico Universitario de Valencia
Valencia València, 46010, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , , Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario Fundacion Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitario Virgen Macarena
Sevilla , , Spain
Royal Cornwall Hospital
Truro Cornwall, TR1 3, United Kingdom
Nottingham University Hospitals City Campus
Nottingham Nottinghamshire, , United Kingdom
St. James s University Hospital
Leeds West Yorkshire, , United Kingdom
Barts Hospital
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

184

Study ID:

NCT04623541

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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