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Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 2026 → May 2027
Primary endpoint added 8 → 9 primary endpoints
See other at-risk trials from Disc Medicine, Inc

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Study sites: 30 to 32
    • Eligibility criteria expanded, about 129 words
    • Secondary endpoints: details revised at 21 of 46 entries
  3. Study sites: 28 to 30v25
  4. Primary completion pushed from Sep 2026 to May 2027v24 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 25 → 28 locations
    • Study completion pushed from Sep 2026 to Jun 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 31 to 46
  5. Study sites: 24 to 25v23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 23 to 24v22
  2. Study sites: 20 to 23v21
  3. Study sites: 17 to 20v20
  4. Study sites: 15 to 17v19
  5. Eligibility criteria shortened, about 158 words
    • Site contacts updated at 13 of 15 sites
    • Study title expanded, about 1 word
    v18
  6. Enrollment target: 56 to 150v17 Show 5 more changesShow less
    • Primary and study completion dates: Oct 2024 to Sep 2026
    • Primary endpoints: 6 to 8
    • Study sites: 14 to 15
    • Eligibility criteria expanded, about 792 words
    • Secondary endpoints: 25 to 31
  7. Eligibility criteria expanded, about 769 words
    • Secondary endpoints: 17 to 25
    • Site details revised at 1 of 14 sites
    • Study title expanded, about 3 words
    v16
  8. Site details revised at 1 of 14 sitesv15
  9. Study sites: 13 to 14v14
  10. Study sites: 12 to 13v13
  11. Study sites: 11 to 12
    • Eligibility criteria expanded, about 21 words
    v12
  12. Study sites: 10 to 11v11
  13. Study sites: 9 to 10v10
  14. Eligibility criteria expanded, about 37 words
    • Site details revised at 7 of 9 sites
    v9
  15. Study sites: 7 to 9v8
  16. Study sites: 6 to 7v7
  17. Re-verified, no change to tracked fieldsv6
  18. Study sites: 5 to 6v5
  19. Study sites: 2 to 5v4
  20. Site details revised at 1 of 2 sitesv3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 30, 2022 to Jun 6, 2022
    v2
  1. Study First Submitted
  • 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.
This phase 1b/2a open-label study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DISC-0974 as well as categorize the effects on hematologic response in participants with myelofibrosis or myelodysplastic syndrome and anemia.
Trial Details
NCT Number NCT05320198
Lead Sponsor Disc Medicine, Inc
Conditions
(from sponsor)		 Myelofibrosis; Anemia, Anemia, Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Myelodysplastic Syndromes
Related terms Anemia, Myelodysplastic Syndromes, Myeloproliferative Disorders, Primary Myelofibrosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov