NCT05206357
Brief 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.
Interventional study
- 1
- 2
- 3
- 4
Would you like to know more about this trial?
|
Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
From 1 Year to 25 Years.
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.
