Go to family friendly version
|Diagnosis||Non-hodgkin Lymphoma||Study Status||Open|
|Age||1 to 25 Years Old||Randomisation||NO|
|Line of treatment||Disease relapse or progression|
|Routes of Treatment Administration||Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Name: ABBV-GMAB-3013|
|Last Posted Update||2023-10-18|
Principal Investigators for Canadian SitesThe Hospital for Sick Children - Dr. Sarah Alexander
CHU Sainte-Justine - Dr. Henrique Bittencourt
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Clinical research contact
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.
Other inclusion criteria may apply
- 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.
Other exclusion criteria may apply