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NCT05835466 · ClinicalTrials.gov record · last posted 2026-05-06

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

StatusRecruiting
PhasePhase 2
Started2023-07-24
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-05-07
critical
Enrollment reduced: 26 → 10 participants
2026-05-07
critical
Primary completion pushed: 2026-12 → 2027-12-31
Trial Details
NCT Number NCT05835466
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Dompé Farmaceutici S.p.A
Conditions Myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (ET-MF), Post Polycythemia Vera Related Myelofibrosis (PV-MF)
Enrollment 10 participants
Start Date 2023-07-24
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06