Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

Study Identifier
M20-429
CT.gov Identifier
NCT05206357
EudraCT Identifier
2021-004555-16
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
    • Study Drug
  • Epcoritamab
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    1 Year - 25 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants \>= 1 and \< 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible. * Disease pathologically confirmed (tumor tissue) by local testing. * Relapsed or primary refractory disease meeting any of the following criteria: * Progressive disease at any time during second-line chemoimmunotherapy (CIT). * Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT. * Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT. * Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy. * Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT. * Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR. * Recovery from toxic effects of prior chemoimmunotherapy. * Performance status by Lansky (\< 16 years old at evaluation) or Karnofsky (\>= 16 years old at evaluation) score \>= 50 or Eastern Cooperative Oncology Group (ECOG) score \<= 2 . * Adequate bone marrow, hepatic, and renal function.
    Exclusion Criteria:
    * Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible). * Other malignancy requiring therapy. * Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

    Protocol Summary

    The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.

    Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.

    Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

    Study Locations

    Location
    Status
    Location
    Lucile Packard Children's Hospital /ID# 240854
    Palo Alto, California, United States, 94304
    Status
    Not applicable
    Location
    Nicklaus Children's Hospital /ID# 241174
    Miami, Florida, United States, 33155-3009
    Status
    Not applicable
    Location
    New York Medical College /ID# 239208
    Valhalla, New York, United States, 10595
    Status
    Not applicable
    Location
    Levine Children's Hospital /ID# 242765
    Charlotte, North Carolina, United States, 28203
    Status
    Not applicable
    Location
    Cincinnati Childrens Hospital Medical Center /ID# 239823
    Cincinnati, Ohio, United States, 45229
    Status
    Not applicable
    Location
    Children's Hospital of Philadelphia - Main /ID# 239294
    Philadelphia, Pennsylvania, United States, 19104-4319
    Status
    Not applicable
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