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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: Recruiting Phase 2 study of Myelofibrosis (PMF) and Post Essential Thrombocythemia Myelofibrosis (ET-MF), sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To estimate the efficacy of reparixin treatment in DIPSS intermediate-2 or high-risk subjects with PMF, post PV-MF, or post ET-MF as assessed by IWG/ELN criteria. The IWG/ELN criteria: CR (complete remission), PR (partial remission), Clinical improvement, Anemia response, Spleen response, Symptoms response, PD (progressive disease), SD (stable disease), Relapse, Cytogenetic remission, and Molecular remission
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 |
What NCT05835466 shows while recruiting
NCT05835466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
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 lists 9 locations in 5 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05835466's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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