Mature B-cell lymphomas
Conditions
Interventions
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Sponsors
Yamagishi Chika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants >= 1 and = 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 . - Adequate bone marrow, hepatic, and renal function.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events, Cmax, AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR) per the International Pediatric Non-Hodgkin Lymphoma Response Criteria, Event-free survival, Overall survival, Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy, Overall response, Duration of response, Duration of CR, Immunogenicity | — |
Countries
Australia, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Republic of Korea, Spain, Taiwan, Turkey, US
Contacts
Public ContactPatients and HCP Contact
AbbVie GK
Outcome results
None listed