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Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion pushed from Dec 2026 to Dec 31, 2027
    • Enrollment reduced: 26 → 10 participants
    • Study completion date: Dec 2028 to Dec 1, 2028
    • Site details revised at 3 of 9 sites
    v9
  2. Eligibility criteria expanded, about 81 wordsv8
  3. Site details revised at 2 of 9 sitesv7
  4. Primary completion date: Dec 2025 to Dec 2026
    • Study sites: 3 to 9
    • Study completion date: Dec 2027 to Dec 2028
    v6
  5. Study sites: 1 to 3v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Mar 2025 to Dec 2025
    • Study completion date: Mar 2026 to Dec 2027
    • Start date: Jun 27, 2023 to Jul 24, 2023
    • Site contact updated
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2023 to Jun 27, 2023
    • Site details revised
    • Collaborator revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF) after prior treatment, and those who are ineligible or refuse treatment, with a Janus kinase inhibitor (JAKi). 26 patients will be enrolled. Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks). After cycle 6, patients may continue receiving reparixin once daily on a 4-week cycle if at least stable disease (SD) is met by IWG-MRT criteria until loss of response, disease progression, unacceptable toxicity, patient/physician withdrawal, or termination of study by sponsor.
Trial Details
NCT Number NCT05835466
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Dompé Farmaceutici S.p.A
Conditions
(from sponsor)		 Myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (ET-MF), Post Polycythemia Vera Related Myelofibrosis (PV-MF)
Related terms Primary Myelofibrosis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov