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

Study Identifier
GCT3013-03
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-504828-25-00
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Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Study Drug
  • Epcoritamab
  • rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
  • Venetoclax
  • Lenalidomide
  • Pirtobrutinib
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    University of California Davis Medical Center Sacramento
    California City, California, United States, 95817
    Status
    Not applicable
    Location
    City of Hope National Medical Center
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    David Geffen School of Medicine
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Stanford Cancer Center
    Palo Alto, California, United States, 94305
    Status
    Not applicable
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