Summary

Eligibility
for people ages 1-25 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Official Title

A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

Keywords

Indolent Non-hodgkin Lymphoma ABBV-GMAB-3013 Epcoritamab Burkitt's or Burkitt-like Lymphoma/Leukemia Diffuse Large B-cell Lymphoma Aggressive Mature (CD20+) B-cell Lymphoma Cancer Relapsed/Refractory Aggressive Mature B-cell Neoplasms Lymphoma Neoplasms Lymphoma, Non-Hodgkin Lymphoma, B-Cell Aggression

Eligibility

You can join if…

Open to people ages 1-25

  • 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 ECOG score <= 2 .
  • Adequate bone marrow, hepatic, and renal function.

You CAN'T join if...

  • 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.

Locations

  • UCSF Helen Diller Family Cancer Research Building /ID# 239140
    San Francisco California 94158 United States
  • Lucile Packard Children's Hospitals - Stanford /ID# 240854
    Palo Alto California 94304-5786 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT05206357
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated