Daratumumab and DA-EPOCH for Plasmablastic Lymphoma
This study is looking at how well a combination of drugs works for people newly diagnosed with plasmablastic lymphoma, a type of cancer. The treatment involves daratumumab, which is a monoclonal antibody (a type of drug that targets specific cells), along with a chemotherapy regimen called DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride). Daratumumab targets a protein called CD38 found on plasmablastic lymphoma cells, aiming to help your immune system fight the cancer. This study aims to see if patients can complete at least 3 cycles of this treatment. You may be able to join if you are 18 or older and have plasmablastic lymphoma that is Stage II-IV, or Stage I with certain features like high LDH or a large tumor. The study is currently unclear on its recruitment status and plans to enroll 15 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 15 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is measured up to the completion of 3 cycles (each cycle is 21 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04139304
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentAIDS Malignancy ConsortiumGovernment-funded
~15 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:CyclophosphamideDaratumumabDoxorubicinDoxorubicin HydrochlorideEtoposidePrednisone
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to the completion of 3 cycles (each cycle is 21 days)
Conditions
Where it's being run
8 sites across 8 statesFlorida1
Illinois1
Maryland1
New York1
North Carolina1
Ohio1
Pennsylvania1
Texas1
Study leadership
- Ariela Noy, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented plasmablastic lymphoma.
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 will allow only HIV positive patients. Participants may be HIV positive, with documentation of HIV infection by means of any one of the following:
Documentation of HIV diagnosis in the medical record by a licensed health care provider;
Documentation of receipt of highly active antiretroviral therapy (HAART) (at least three different medications) by a licensed health care provider (documentation may be a record of an HAART prescription in the participant?s medical record, a written prescription in the name of the participant for HAART, or pill bottles for HAART with a label showing the participant?s name);
HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
NOTE: A ?licensed? assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies.
Participants without HIV infection must have evidence of a negative result using any licensed HIV screening antibody assay and/or HIV antibody/antigen combination assay.
Participants must have measurable disease (unless marrow-only disease is present), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter) as \>= 15 mm (\>= 1.5cm) by computed tomography (CT) or positron emission tomography (PET) scan or evaluable by bone marrow.
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%).
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 upper limit of normal (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 (serum glutamic oxaloacetic transaminase \[SGOT\])/ALT (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (=\< 5 x ULN is acceptable if liver metastases are present).
Creatinine =\< 1.5 x institutional ULN OR glomerular filtration rate (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%.
CD4 count \>= 100 cell/mL for HIV-positive participants.
If HIV-positive, participant must not have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past year.
If HIV-positive, participant should have concurrent treatment with effective highly active antiretroviral therapy (HAART) or agree to start HAART.
The effects of daratumumab on the developing human fetus are unknown. For this reason and because another monoclonal antibody (mAb), rituximab, crosses the placenta and other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation, and 90 days after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with female partners treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of daratumumab administration.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) is \<50% of predicted normal. Note that FEV1 testing also is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is \<50% of predicted normal.
Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.) 20. Participants with prior malignancies are ineligible unless:
Treatment for the prior malignancy was completed at least 2 years prior to the lymphoma treatment start date and the participant has no evidence of the concurrent malignancy OR
The concurrent malignancy is clinically stable and does not require tumor-directed treatment.
What this trial measures
- 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)Up to the completion of 3 cycles (each cycle is 21 days)
The proportion of participants completing \>= 3 cycles of DA-EPOCH with daratumumab will be calculated with the denominator being eligible, evaluable participants.