Trials / Recruiting
RecruitingNCT05835466
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
Phase II Study of Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 120]
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Myelofibrosis (PMF)
- Post Essential Thrombocythemia Myelofibrosis (ET-MF)
- Post Polycythemia Vera Related Myelofibrosis (PV-MF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | reparixin | reparixin at 1200mg TID three times per day. |
Timeline
- Start date
- 2023-07-24
- Primary completion
- 2026-12-01
- Completion
- 2028-12-01
- First posted
- 2023-04-28
- Last updated
- 2026-01-07
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05835466. Inclusion in this directory is not an endorsement.