Relapsed/Refractory Aggressive Mature B-cell Neoplasms
Conditions
Brief summary
The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.
Detailed description
CR per the International Pediatric Non-Hodgkin Lymphoma Response Criteria, Event-free survival (EFS), Overall survival (OS), Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy, Overall response (OR), Duration of response (DOR), Duration of CR (DOCR), Immunogenicity ([ADA] and neutralizing anti-drug antibodies (nAb))
Interventions
Sponsors
AbbVie Deutschland GmbH & Co. KG, AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are safety and tolerability, including AESIs of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| CR per the International Pediatric Non-Hodgkin Lymphoma Response Criteria, Event-free survival (EFS), Overall survival (OS), Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy, Overall response (OR), Duration of response (DOR), Duration of CR (DOCR), Immunogenicity ([ADA] and neutralizing anti-drug antibodies (nAb)) | — |
Countries
Belgium, Czechia, France, Germany, Italy, Spain
Outcome results
None listed