OncoMatch/Clinical Trials/NCT04139304
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Is NCT04139304 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for plasmablastic lymphoma.
Treatment: Cyclophosphamide · Daratumumab · Doxorubicin · Doxorubicin Hydrochloride · Etoposide · Prednisone · Vincristine · Vincristine Sulfate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy or radiotherapy for this lymphoma
Exception: palliative radiation for medical emergencies; one cycle of combination chemotherapy (including EPOCH or CHOP-like therapy) within 21-28 days prior to study; one prior cycle of limited therapy including cyclophosphamide and/or glucocorticoids up to 28 days prior (cyclophosphamide completed >=14 days prior)
Prior cytotoxic chemotherapy or radiotherapy for this lymphoma other than palliative radiation for medical emergencies (like cord compression) or the following chemotherapy: ... (see criteria for details)
Cannot have received: anthracycline
Exception: any prior exposure to liposomal doxorubicin allowed if LVEF >=45%; prior doxorubicin at investigator discretion
Participants must not have had previous anthracycline treatment within the last two years, except for liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the LVEF is ≥45%. It is at the discretion of the investigator if prior exposure to doxorubicin is acceptable.
Cannot have received: daratumumab (daratumumab)
Participants who have previously received daratumumab for another indication.
Lab requirements
Blood counts
Absolute neutrophil count >= 1,000 cells/mcL unless decreased due to bone marrow involvement; Platelets >= 75,000 cells/mcL unless decreased due to bone marrow involvement
Kidney function
Creatinine <= 1.5 x institutional ULN OR GFR >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (Cockcroft-Gault formula)
Liver function
Total bilirubin <= 1.5 x institutional ULN (< 3.0 x ULN for patients with Gilbert syndrome; <= 3.5 mg/dL if secondary to antiretroviral therapy and direct bilirubin is normal and AST/ALT <= 3 x ULN); AST/ALT <= 2.5 x ULN (<= 5 x ULN if liver metastases present)
Cardiac function
Ejection fraction on ECHO or MUGA >= 45%
Absolute neutrophil count >= 1,000 cells/mcL unless decreased due to bone marrow involvement. Platelets >= 75,000 cells/mcL unless decreased due to bone marrow involvement. Total bilirubin <= 1.5 x institutional ULN (< 3.0 x ULN for patients with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be <= 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 x the upper limit of normal. AST/ALT <= 2.5 x institutional ULN (<= 5 x ULN is acceptable if liver metastases are present). Creatinine <= 1.5 x institutional ULN OR GFR >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft-Gault formula. Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multigated acquisition scan (MUGA) that is at or above 45%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami Miller School of Medicine · Miami, Florida
- University of Illinois at Chicago · Chicago, Illinois
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, Maryland
- Memorial Sloan Kettering Cancer Center · New York, New York
- University of North Carolina - Chapel Hill · Chapel Hill, North Carolina
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