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JAK1/2 Inhibitor Ruxolitinib for Relapsed/Refractory Immune Bone Marrow Failure

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 108 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 49 words
  2. Minor Re-verified, no change to tracked fieldsv107
  3. Notable Primary endpoint(s) modified
    • Results first posted: Jul 15, 2026
    • Secondary endpoints revised (8)
    v106
  4. Notable Enrollment reduced: 145 → 13 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v105
  5. Minor Re-verified, no change to tracked fieldsv104
  6. Notable Primary completion moved earlier from Jun 3, 2030 to Jul 22, 2025v103
  7. Minor Re-verified, no change to tracked fieldsv102
  8. Minor Eligibility criteria shortened, about 4 wordsv101
  9. Minor Eligibility criteria shortened, about 4 wordsv100
  10. Minor 3 versions Re-verified since May 31, 2025, no change to tracked fieldsv97-v99
  11. Minor Eligibility criteria shortened, about 7 wordsv96
  12. Minor 3 versions Re-verified since Nov 15, 2024, no change to tracked fieldsv93-v95
  13. Minor Eligibility criteria shortened, about 1 wordv92
  14. Minor 3 versions Re-verified since Jul 3, 2024, no change to tracked fieldsv89-v91
  15. Minor Eligibility criteria expanded, about 42 wordsv88
  16. Minor Start date changed from estimate of Feb 27, 2024 to Feb 20, 2024v87
  17. Minor Start date: Feb 26, 2024 to Feb 27, 2024v86
  18. Minor Start date: Feb 25, 2024 to Feb 26, 2024v85
  19. Minor Start date: Feb 22, 2024 to Feb 25, 2024v84
  20. Minor Start date: Feb 20, 2024 to Feb 22, 2024v83
  21. Minor Start date: Feb 19, 2024 to Feb 20, 2024v82
  22. Minor Start date: Feb 18, 2024 to Feb 19, 2024v81
  23. Minor Start date: Feb 15, 2024 to Feb 18, 2024v80
  24. Minor Start date: Feb 14, 2024 to Feb 15, 2024v79
  25. Minor Start date: Feb 12, 2024 to Feb 14, 2024v78
  26. Minor Start date: Feb 11, 2024 to Feb 12, 2024v77
  27. Minor Start date: Feb 7, 2024 to Feb 11, 2024v76
  28. Minor Start date: Feb 6, 2024 to Feb 7, 2024v75
  29. Minor Start date: Feb 5, 2024 to Feb 6, 2024v74
  30. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 29, 2024 to Feb 5, 2024
    • Site details revised
    v73
  31. Minor Start date: Jan 28, 2024 to Jan 29, 2024v72
  32. Minor Start date: Jan 25, 2024 to Jan 28, 2024v71
  33. Minor Start date: Jan 24, 2024 to Jan 25, 2024v70
  34. Minor Start date: Jan 23, 2024 to Jan 24, 2024v69
  35. Minor Start date: Jan 19, 2024 to Jan 23, 2024v68
  36. Minor Start date: Jan 18, 2024 to Jan 19, 2024v67
  37. Minor Start date: Jan 17, 2024 to Jan 18, 2024v66
  38. Minor Start date: Jan 16, 2024 to Jan 17, 2024v65
  39. Minor Start date: Jan 12, 2024 to Jan 16, 2024v64
  40. Minor Start date: Jan 11, 2024 to Jan 12, 2024v63
  41. Minor Start date: Jan 10, 2024 to Jan 11, 2024v62
  42. Minor Start date: Jan 9, 2024 to Jan 10, 2024v61
  43. Minor Start date: Jan 8, 2024 to Jan 9, 2024v60
  44. Minor Start date: Jan 4, 2024 to Jan 8, 2024v59
  • 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: Immune bone marrow failure is a condition that occurs when a person s immune system attacks the cells of the bone marrow. This can lead to diseases including different types of anemias and blood cancers. Some of these diseases can be deadly. Better treatments are needed. Objective: To test a drug (ruxolitinib) in people with different types of immune bone marrow failure. Eligibility: Adults aged 18 and older with an immune bone marrow failure. Design: Participants will be screened. They will have a physical exam. They will give samples of blood and saliva. They will have a bone marrow biopsy: A large needle will be inserted into a small cut to remove a sample of the soft tissue inside the bone. Some participants may have a skin biopsy: A small piece of skin will be removed. Some may have a computed tomography (CT) scan: They will lie on a table that slides into a donut-shaped machine that uses X-rays to make pictures of the inside of the body. Ruxolitinib is a tablet taken by mouth. Participants will take the drug twice a day for up to 6 months. Participants will have blood tests every week while they are taking the drug. These tests can be done by the participant s own physician and the results sent to the researchers. Participants will have clinic visits after taking the drug for 3 months and 6 months and then after 1, 2, and 3 years. The blood tests and bone marrow biopsy will be repeated. Participants who improve while taking the drugs may go on to an extension phase of the study.
Trial Details
NCT Number NCT05998408
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Severe Aplastic Anemia, Single Lineage Cytopenias, T-LGL, Hypoplastic MDS
Related terms Anemia, Aplastic
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov