Phase II Study of Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 120]
Icahn School of Medicine at Mount Sinai
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Be ≥ 18 years of age at time of signing the informed consent form (ICF) * Willing to voluntarily sign the ICF * Have a pathologically confirmed diagnosis of PMF, post-ET-MF, or post-PV-MF as per the World Health Organization (WHO) diagnostic criteria with intermediate-2 or higher risk disease by DIPSS * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Willing to undergo a bone marrow biopsy at screening o A bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice. * Be…
Interventions
- Drugreparixin
reparixin at 1200mg TID three times per day.
Locations (9)
- Moffitt Cancer CenterTampa, Florida
- Emory UniversityAtlanta, Georgia
- Roswell Park Cancer InstituteBuffalo, New York
- Ruttenberg Treatment CenterNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- NewYork-Presbyterian/Weill Cornell Medical CenterNew York, New York