Actively Recruiting
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Led by AIDS Malignancy Consortium · Updated on 2025-06-29
15
Participants Needed
8
Research Sites
475 weeks
Total Duration
On this page
Sponsors
A
AIDS Malignancy Consortium
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and immunophenotypically confirmed plasmablastic lymphoma by biopsy
- Stage II-IV disease or stage I with elevated lactate dehydrogenase (LDH) or bulky tumor larger than 7.5 cm
- Known HIV status; enrollment limited to 7 HIV-negative patients, then only HIV-positive
- Measurable disease with at least one lesion 1.5 cm or larger by CT or PET scan, or evaluable bone marrow involvement
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky score at least 50%)
- Absolute neutrophil count at least 1,000 cells/mcL unless due to bone marrow involvement
- Platelet count at least 75,000 cells/mcL unless due to bone marrow involvement
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), with exceptions for Gilbert syndrome and certain antiretroviral therapy effects
- AST/ALT levels less than or equal to 2.5 times ULN (up to 5 times if liver metastases present)
- Creatinine less than or equal to 1.5 times ULN or glomerular filtration rate (GFR) at least 45 mL/min/1.73 m2
- Adequate cardiac function with ejection fraction at or above 45%
- CD4 count at least 100 cells/mL for HIV-positive patients
- No AIDS-defining opportunistic infections in past year for HIV-positive patients
- If HIV-positive, concurrent or planned effective highly active antiretroviral therapy (HAART)
- Women of childbearing potential and men must agree to use effective contraception during study and 90 days after
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy or radiotherapy for this lymphoma except limited palliative radiation or one cycle of chemotherapy started 21 to 28 days before study
- Current use of other investigational agents
- Prior anthracycline treatment within 2 years except liposomal doxorubicin with normal heart function
- Previous treatment with daratumumab
- Use of strong CYP3A4 inhibitors like cobicistat, indinavir, or ritonavir without switching to alternatives
- Peripheral neuropathy grade 3 or higher, or neuropathic pain grade 2 or higher
- Expected survival less than 2 months
- Known brain metastases from solid tumors
- Known or suspected brain or spinal cord lymphoma involvement except asymptomatic leptomeningeal disease
- Hepatitis B surface antigen positive or detectable HBV DNA by PCR
- Hepatitis C antibody positive with liver cirrhosis or abnormal liver tests
- Allergy or intolerance to daratumumab or similar agents
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues
- Pregnancy or breastfeeding
- Inability to comply with study requirements or provide informed consent
- Serious ongoing non-malignant disease or active opportunistic infections
- Major surgery within 4 weeks before study (except splenectomy)
- Recent myocardial infarction within 6 months or significant heart disease
- Severe lung disease (COPD with FEV1 under 50%, moderate/severe asthma or recent uncontrolled asthma)
- Prior malignancies unless treated over 2 years ago with no current evidence or clinically stable without treatment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
5
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
6
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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