Full Title
A Multicenter, Open-label Feasibility and Randomized Phase II Study of Daratumumab with Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma with or without HIVPurpose
Plasmablastic lymphoma is a type of B-cell non-Hodgkin lymphoma (NHL). The purpose of this study is to determine if adding daratumumab to a standard chemotherapy regimen (DA-EPOCH) is a safe way to increase the effectiveness of treatment in people with plasmablastic lymphoma.
Daratumumab targets cells that produce the protein CD38, which is found at high levels in plasmablastic lymphoma cells. It is used to treat multiple myeloma. Its use in this study is considered investigational. EPOCH is a chemotherapy regimen that combines the drugs etoposide, vincristine, cyclophosphamide, doxorubicin, and prednisone and is used to treat lymphoma. Daratumumab and EPOCH are given intravenously (by vein).
Protocol
20-033
Phase
Phase I/II (phases 1 and 2 combined)
Investigator
Co-Investigators
Diseases
Locations
ClinicalTrials.gov ID
NCT04139304
ClinicalTrials.gov