Actively Recruiting
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-06
10
Participants Needed
9
Research Sites
279 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
D
Dompé Farmaceutici S.p.A
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reparixin in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 120)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of signing the informed consent form
- Willing to voluntarily sign the informed consent form
- Have a confirmed diagnosis of primary myelofibrosis, post-essential thrombocythemia myelofibrosis, or post-polycythemia vera myelofibrosis with intermediate-2 or higher risk disease
- Have an ECOG performance status of 2 or less
- Willing to undergo a bone marrow biopsy at screening or have a recent biopsy within 90 days approved by the study chair
- Be refractory, resistant, intolerant, or inappropriate for Janus kinase inhibitor therapy as defined by specific criteria
- Recovery to Grade 1 or baseline of any toxicities from prior treatments, excluding alopecia
- At least two weeks since the last dose of any myelofibrosis-directed or investigational treatments before starting reparixin
- Have adequate organ function as defined by liver enzymes, bilirubin, creatinine clearance, platelet count, blast count, and absolute neutrophil count thresholds
- Life expectancy of at least six months
- Agree to use adequate contraception if of childbearing potential or male during and for 120 days after study
- Ability to follow the study visit schedule and protocol requirements
You will not qualify if you...
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring treatment within the past 6 months
- Other invasive cancers within the last 3 years except certain skin and localized prostate or cervical cancers
- Moderate or severe cardiovascular disease including recent heart attack, unstable angina, severe heart failure, or uncontrolled hypertension
- Major ECG abnormalities not responding to treatment
- Active serious infections
- Serious or unstable medical or psychiatric conditions that pose unacceptable risk or interfere with study participation
- Recent hematopoietic cell transplant or ongoing immunosuppressive therapy post-transplant
- Known HIV or active hepatitis A, B, or C infection
- Gastrointestinal conditions that could affect reparixin absorption or unresolved nausea, vomiting, or diarrhea beyond mild severity
- Immediate family members involved in the study unless approved by the review board
- Organ transplant recipients other than bone marrow transplant
- Pregnant or breastfeeding women
- History of splenectomy
- Known hypersensitivity to sulfonamides or NSAIDs including ibuprofen, except isolated sulphonamide antibiotic allergy
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
4
Ruttenberg Treatment Center
New York, New York, United States, 10029
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
7
Wake Forest Baptist Health Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
G
Gillian Sanchez
CONTACT
S
Shakira Forde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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