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A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

Study acronym: MANIFEST-3
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 118 → 125 locations
  2. Minor Trial sites expanded: 111 → 118 locations
  3. Minor Study sites: 111 to 118
  4. Minor Trial sites expanded: 103 → 110 locations
  5. Minor Trial sites expanded: 98 → 103 locations
  6. Minor Study sites: 98 to 103
  7. Minor Trial sites expanded: 90 → 96 locations
  8. Minor Trial sites expanded: 77 → 88 locations Start date moved earlier from Jun 16, 2026 to May 27, 2026 · Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 10 of 24 entries · 1 more Show 4 more changesShow less
    • Start date moved earlier from Jun 16, 2026 to May 27, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 10 of 24 entries
    • Study description expanded, about 5 words
  9. Minor Trial sites expanded: 70 → 73 locations Trial sites expanded: 67 → 70 locationsv26 Show 1 more changeShow less
    • Trial sites expanded: 67 → 70 locations
  10. Minor Study sites: 67 to 70v25
  11. Minor Trial sites expanded: 57 → 67 locationsv24
  12. Minor Trial sites expanded: 53 → 56 locationsv23
  13. Minor Trial sites expanded: 49 → 53 locations Start date: Jun 8, 2026 to Jun 16, 2026v22 Show 1 more changeShow less
    • Start date: Jun 8, 2026 to Jun 16, 2026
  14. Minor Study sites: 49 to 53 Start date: Jun 16, 2026 to Jun 8, 2026v21 Show 1 more changeShow less
    • Start date: Jun 16, 2026 to Jun 8, 2026
  15. Minor Study sites: 47 to 49v20
  16. Minor Trial sites expanded: 30 → 47 locationsv19
  17. Minor Study sites: 29 to 30v18
  18. Minor Trial sites expanded: 25 → 29 locations Start date: Jun 12, 2026 to Jun 16, 2026v17 Show 1 more changeShow less
    • Start date: Jun 12, 2026 to Jun 16, 2026
  19. Minor Trial sites expanded: 20 → 25 locations Start date: May 27, 2026 to Jun 12, 2026v16 Show 1 more changeShow less
    • Start date: May 27, 2026 to Jun 12, 2026
  20. Minor Study sites: 18 to 20v15
  21. Minor Trial sites expanded: 15 → 18 locationsv14
  22. Minor Study sites: 13 to 15v13
  23. Minor Study sites: 11 to 13v12
  24. Minor Trial sites expanded: 6 → 9 locationsv11
  25. Minor Study sites: 9 to 10v10
  26. Minor Study sites: 6 to 9 Start date changed from estimate of May 15, 2026 to May 27, 2026v9 Show 1 more changeShow less
    • Start date changed from estimate of May 15, 2026 to May 27, 2026
  27. Minor Study sites: 5 to 6v8
  28. Minor Study sites: 4 to 5v7
  29. Minor Study sites: 3 to 4v6
  30. Notable Start date: Apr 15, 2026 to May 15, 2026 Study sites: 1 to 3 · Completion date: Nov 28, 2030 to Dec 27, 2030v5 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Completion date: Nov 28, 2030 to Dec 27, 2030
  31. Notable Recruitment opened Study sites: 0 to 1 · Completion date: Dec 2, 2030 to Nov 28, 2030 · Start date: Apr 17, 2026 to Apr 15, 2026v4 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Dec 2, 2030 to Nov 28, 2030
    • Start date: Apr 17, 2026 to Apr 15, 2026
  32. Minor Completion date: Dec 27, 2030 to Dec 2, 2030 Start date: Apr 15, 2026 to Apr 17, 2026v3 Show 1 more changeShow less
    • Start date: Apr 15, 2026 to Apr 17, 2026
  33. Minor Re-verified, no change to tracked fieldsv2
  34. Minor 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.
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The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.
Trial Details
NCT Number NCT07357727
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov