Clinical Trial

A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma

Recruiting Early Phase 1
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Summary
This feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells have high levels of a protein called CD38. Daratumumab is a monoclonal antibody that specifically targets CD38 expressing cells, and may help the body's immune system attack the cancer and interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab may enhance the effectiveness of a standard chemotherapy (DA-EPOCH) in patients with plasmablastic lymphoma.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2019-10-23; most recent amendment 2026-05-28.
Status change: Active, Not Recruiting → Recruiting 2025-06-26
Status change: Recruiting → Active, Not Recruiting 2024-09-10
Status change: Active, Not Recruiting → Recruiting 2021-06-10
Status change: Suspended → Active, Not Recruiting 2021-01-07
Status change: Recruiting → Suspended 2020-11-24
Status change: Not Yet Recruiting → Recruiting 2020-01-27
Trial Details
NCT Number NCT04139304
Lead Sponsor AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI), Janssen Scientific Affairs, LLC, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, AIDS and Cancer Specimen Resource, The Emmes Company, LLC
Conditions Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
Enrollment 15 participants
Start Date 2021-05-24
Primary Completion 2029-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-01