Chronic Lymphocytic Leukemia Clinical Trial
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome
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).
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.
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.
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There are 47 Locations for this study
Tuscaloosa Alabama, 35487, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Stanford California, 94305, United States
Hollywood Florida, 33021, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48190, United States
Detroit Michigan, 48202, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Kogarah New South Wales, 2217, Australia
Geelong Victoria, 3220, Australia
Bruges , 8000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Hradec Králové Nový Hradec Králové, 500 0, Czechia
København Hovedstaden, 2100, Denmark
Aalborg , 9100, Denmark
Odense , 5000, Denmark
Roskilde , 4000, Denmark
Vejle , 7100, Denmark
Århus , 8000, Denmark
Montpellier Occitania, 34090, France
Nantes Pays De La Loire, 44000, France
Paris , 75010, France
Paris , 75013, France
Pessac , 33604, France
Vandœuvre-lès-Nancy , 54500, France
Kiel , 24105, Germany
Koeln , 50937, Germany
Haifa , , Israel
Jerusalem , , Israel
Petah Tikva , 49414, Israel
Tel Aviv-Yafo , , Israel
Brescia , , Italy
Milano , 20132, Italy
Novara , 28100, Italy
Roma , 00168, Italy
Maastricht Limburg, 6229 , Netherlands
Dordrecht South Holland, 3318 , Netherlands
Amsterdam , 1105, Netherlands
Groningen , 9713, Netherlands
Utrecht , 3584 , Netherlands
Barcelona , 08036, Spain
Madrid , 28034, Spain
Truro Cornwall, TR1 3, United Kingdom
London , EC1A , United Kingdom
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