A Phase 2 interventional study of Daratumumab SC in Lymphoma, Primary Effusion, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Background:
Primary effusion lymphoma (PEL), plasmablastic lymphoma (PBL), and Multicentric Castleman Disease (MCD) are aggressive forms of cancer that affects cells in the immune system and lymph nodes. How they develop is not well understood, and these diseases do not respond well to standard treatments for other types of lymphomas.
Objective:
To test a drug treatment (daratumumab SC) in people with PEL, PBL, or MCD.
Eligibility:
People aged 18 and older with PEL, PBL, or MCD who must have failed to respond to therapy or they must be unable to receive standard treatment for the disease.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart and lung function. They may need to have a biopsy: tissue or fluid will be collected. They will have an eye exam.
Daratumumab SC is given as an injection into the fat under the skin in the abdomen. This takes 3 to 5 minutes. Participants will receive the treatment once a week for 8 weeks; then every 2 weeks for 16 weeks; then every 4 weeks for up to 24 months.
Participants will have other tests during the study period. These may include lumbar punctures: A needle will be inserted between the bones of the spine to draw some fluid from the area around the spinal cord. Participants may also have a thoracentesis: A needle or plastic tube will be inserted into the space around the lungs to withdraw fluid. Participants will have more imaging scans and blood tests.
Follow-up visits will continue after treatment ends. Participants will be in the study for up to 5 years.
Background
Objective
-To evaluate the partial response (PR) plus complete response (CR) rate (further referred to as the overall response rate [ORR]) of daratumumab SC in participants with relapsed/refractory PEL or PBL and/or symptomatic KSHV-MCD or who are ineligible for front-line chemotherapy
Eligibility
Participants with PEL or PBL must have:
Participants with KSHV-MCD must have:
Design
Participants with PEL or PBL must meet the following criteria:
Adequate hematological and renal functions as defined below:
Participants with KSHV-MCD must meet the following criteria:
Adequate hematological and renal functions as defined below:
At least one clinical symptom attributed to KSHV-MCD
At least one laboratory abnormality attributed to KSHV-MCD
EXCLUSION CRITERIA:
EXCEPTIONS:
If the elevated total bilirubin or AST/ALT are due to ART or lymphoma
Uncontrolled cardiac arrhythmia
Treatment with daratumumab SC
Drug: Daratumumab SC
Daratumumab SC (daratumumab and hyaluronidase) is administered subcutaneously (SC) as 1800 mg/30,000 units weekly for a total of 8 weeks followed by every 2 weeks for a total of 16 weeks followed by every 4 weeks for up to 96 weeks
Overall response rate (ORR)
Percentage of participants with the best overall response of CR or PR to therapy
Time frame: at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Safety of daratumumab
Adverse events (AEs) will be reported by type and grade of toxicity
Time frame: From first dose through 30 days after the end of treatment
Plan to share: Yes — All collected IPD will be shared
Supporting information: Study protocol, Sap, Icf
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Lymphoma, Primary Effusion
National Cancer Institute (NCI)