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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05835466
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis (PMF)
  • Post Essential Thrombocythemia Myelofibrosis (ET-MF)
  • Post Polycythemia Vera Related Myelofibrosis (PV-MF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • reparixin — DRUG
    reparixin at 1200mg TID three times per day.

Study Details

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.

Key Dates

Start date
Jul 24, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Reparixin
    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.

Primary Outcome Measure

Efficacy of reparixin treatment per IWG/ELN criteria [ Time Frame: Cycle 6 (each cycle is 4 weeks) Response Assessment ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Andrew Kuykendall, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Anthony Hunter, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Eunice Wang, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Brian Chernak, MD (PRINCIPAL_INVESTIGATOR)
NewYork-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10065
Ghaith Abu-Zeinah, MD (PRINCIPAL_INVESTIGATOR)
Ruttenberg Treatment CenterNew YorkNew York10029
Marina Kremyanskaya (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Health Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Rupali Bhave, MD (PRINCIPAL_INVESTIGATOR)
The Cleveland Clinic FoundationClevelandOhio44195
Aaron Gerds, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Shivani Handa, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FLEmory University· Atlanta, GARoswell Park Cancer Institute· Buffalo, NYMemorial Sloan Kettering Cancer Center· New York, NYNewYork-Presbyterian/Weill Cornell Medical Center· New York, NYRuttenberg Treatment Center· New York, NY

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