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Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 257 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 28 → 40 participants Eligibility criteria expanded, about 21 words · Study description expanded, about 51 words Show 2 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Study description expanded, about 51 words
  2. 5 versions Re-verified since Mar 17, 2026, no change to tracked fieldsv252-v256
  3. Study description expanded, about 26 words Eligibility criteria expanded, about 5 wordsv251 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. 4 versions Re-verified since Jun 25, 2025, no change to tracked fieldsv247-v250
  5. Study Identification, Study Status, Study Description, Conditionsv246
Show 38 earlier versionsHide 38 earlier versions
  1. Re-verified, no change to tracked fieldsv245
  2. Eligibility criteria revisedv244 See this version in full on ClinicalTrials.gov ↗
  3. Study description expanded, about 44 wordsv243 See this version in full on ClinicalTrials.gov ↗
  4. 2 versions Re-verified since Feb 13, 2025, no change to tracked fieldsv241-v242
  5. Study Status, Study Descriptionv240
  6. 6 versions Re-verified since Aug 23, 2024, no change to tracked fieldsv234-v239
  7. Start date changed from estimate of Jul 17, 2024 to Jul 10, 2024v233
  8. Start date: Jul 15, 2024 to Jul 17, 2024v232
  9. Start date: Jul 14, 2024 to Jul 15, 2024v231
  10. Start date: Jul 11, 2024 to Jul 14, 2024v230
  11. Start date: Jul 9, 2024 to Jul 11, 2024v229
  12. Start date: Jul 8, 2024 to Jul 9, 2024v228
  13. Start date: Jul 7, 2024 to Jul 8, 2024v227
  14. Start date: Jul 4, 2024 to Jul 7, 2024v226
  15. Start date: Jul 3, 2024 to Jul 4, 2024v225
  16. Start date: Jul 2, 2024 to Jul 3, 2024v224
  17. Start date: Jul 1, 2024 to Jul 2, 2024v223
  18. Start date: Jun 30, 2024 to Jul 1, 2024v222
  19. Start date: Jun 27, 2024 to Jun 30, 2024v221
  20. Start date: Jun 26, 2024 to Jun 27, 2024v220
  21. Start date: Jun 23, 2024 to Jun 26, 2024v219
  22. Start date: Jun 20, 2024 to Jun 23, 2024v218
  23. Start date: Jun 19, 2024 to Jun 20, 2024v217
  24. Start date: Jun 18, 2024 to Jun 19, 2024v216
  25. Start date: Jun 17, 2024 to Jun 18, 2024v215
  26. Start date: Jun 16, 2024 to Jun 17, 2024v214
  27. Start date: Jun 13, 2024 to Jun 16, 2024v213
  28. Start date: Jun 12, 2024 to Jun 13, 2024v212
  29. Start date: Jun 11, 2024 to Jun 12, 2024v211
  30. Start date: Jun 10, 2024 to Jun 11, 2024v210
  31. Start date: Jun 9, 2024 to Jun 10, 2024v209
  32. Start date: Jun 6, 2024 to Jun 9, 2024v208
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05907759
Lead Sponsor National Cancer Institute (NCI)
Conditions Lymphoma, Primary Effusion
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov