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

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,

Trial Details

NCT ID
NCT04139304
Phase
EARLY_PHASE1
Sponsor
AIDS Malignancy Consortium
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Cyclophosphamide
  • Daratumumab
  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Etoposide
  • Prednisone
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • New York, New York, United States|40.71427,-74.00597
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

  • Participants must have histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented plasmab…
  • Stage II-IV disease (Ann Arbor staging criteria) or stage I disease with elevated lactate dehydrogenase (LDH) or bulky tumor (\> 7.5 cm).
  • Known HIV status. At most 7 HIV negative patients will be allowed on the study. Once 7 HIV negative patients have been enrolled, future enrollment …
  • Documentation of HIV diagnosis in the medical record by a licensed health care provider;

For full eligibility, visit ClinicalTrials.gov.

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