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NCT05835466 · ClinicalTrials.gov registry record · Phase 2
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
A Phase 2 study of Myelofibrosis (PMF) and Post Essential Thrombocythemia Myelofibrosis (ET-MF), sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 9
- Study locations
NCT05835466 is a Phase 2 study of Myelofibrosis (PMF) and Post Essential Thrombocythemia Myelofibrosis (ET-MF) that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 26 participants. The trial reports 9 study locations across 5 states.
The verdict
NCT05835466, a Phase 2 study of Myelofibrosis (PMF) and Post Essential Thrombocythemia Myelofibrosis (ET-MF), is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 9
- Study locations
Study 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 Studied
Interventions
- DRUG reparixin
Study Locations (9)
New York
- Roswell Park Cancer Institute - Buffalo
- Ruttenberg Treatment Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- NewYork-Presbyterian/Weill Cornell Medical Center - New York
Ohio
- The Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University - Atlanta
North Carolina
- Wake Forest Baptist Health Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835466
The ClinicalTrials.gov registry entry for NCT05835466 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Myelofibrosis (PMF) appearing as the primary indexed condition, and to 1 intervention - of which reparixin is the first listed.
NCT05835466 reports 9 study locations spanning 5 distinct geographic areas - top geographies include New York, Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT05835466 about?
NCT05835466 is a clinical study titled "Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)". 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 in...
What is the current status of trial NCT05835466?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-07-24. Estimated completion is 2028-12.
What conditions does trial NCT05835466 study?
This clinical trial studies the following conditions: Myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (ET-MF), Post Polycythemia Vera Related Myelofibrosis (PV-MF).
What interventions are being tested in trial NCT05835466?
The interventions under investigation include: reparixin (DRUG).
Who is sponsoring clinical trial NCT05835466?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835466 being conducted?
This trial has 9 study locations across Florida, Georgia, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Myelofibrosis (PMF)
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Post Essential Thrombocythemia Myelofibrosis (ET-MF)
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Florida
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