A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Sponsor study identifier
Secondary identifiers
interventional
40
1 country
1
Study Start
July 10, 2024
Actual (reported)Primary Completion
August 1, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2023
Actual (reported)June 18, 2023
Actual (reported)July 10, 2024
Actual (reported)August 1, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall response rate (ORR)
Percentage of participants with the best overall response of CR or PR to therapy
at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Safety of daratumumab
From first dose through 30 days after the end of treatment
Treatment with 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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Robert Yarchoan, M.D.
National Cancer Institute (NCI)
First Submitted
June 15, 2023
First Posted
June 18, 2023
Study Start
July 10, 2024
Actual (reported)Primary Completion
August 1, 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10-13
All collected IPD will be shared
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Source: ClinicalTrials.gov.
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