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

Conditions

• 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
• Plasmablastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Daratumumab — BIOLOGICAL
  Given IV
• Doxorubicin — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Prednisone — DRUG
  Given PO
• Vincristine — DRUG
  Given IV
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

May 24, 2021

Status verified

May 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2030

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (daratumumab, DA-EPOCH)
  Patients receive daratumumab IV on days 1 (± 3 days), 8 (± 2 days), and 15 (± 2 days), of cycles 1-3, and on day 1 of cycles 4-6. Patients also receive etoposide, doxorubicin hydrochloride, and vincristine sulfate IV continuous over 96 hours on days 1-4, prednisone PO on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for up to 6 cycles in absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of newly diagnosed plasmablastic lymphoma patients who complete at least 3 cycles of daratumumab with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) [ Time Frame: Up to the completion of 3 cycles (each cycle is 21 days) ]

Locations (8)

Find similar trials in Miami, FL

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