Reparixin for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Calcineurin inhibitors

Disqualifiers: Cardiovascular disease, Active infection, Organ transplant, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial requires that at least two weeks must have passed since the last dose of any myelofibrosis-directed drug treatments, except for hydroxyurea, before enrolling. This means you may need to stop certain medications before starting the trial.

Research Team

Aaron Gerds, MD, MS

Principal Investigator

Cleveland Clinic Taussig Cancer Institute

Marina Kremyanskaya, PhD, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults with intermediate-2 or high-risk primary myelofibrosis, post-ET/PV MF who have not responded well to JAK inhibitor treatment or can't take it. Participants should be in good enough health to perform daily activities with minimal assistance (ECOG ≤ 2), have proper organ function, and a life expectancy of at least six months. Pregnant women and those with recent severe heart issues, active serious infections, or other unstable conditions are excluded.

Inclusion Criteria

It has been over two weeks since my last myelofibrosis treatment.

Life expectancy of at least six months

Women of childbearing potential (WCBP) and men must agree to use adequate contraception

Exclusion Criteria

I had a stem cell transplant less than 100 days ago.

I haven't used any experimental drugs or devices in the last 4 weeks.

Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks)

24 weeks

6 visits (in-person)

Extension

Participants may continue receiving reparixin once daily on a 4-week cycle if at least stable disease is met by IWG-MRT criteria

Indefinite, based on response

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Reparixin (Chemokine Receptor Antagonist)

Trial Overview The study tests the efficacy and safety of Reparixin taken orally three times daily over a 24-week period in patients with certain types of myelofibrosis after previous treatments have failed. The trial aims to enroll 26 patients who may continue treatment if they show no disease progression after the initial cycles.

Participant Groups

Group I: Reparixin Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Dompé Farmaceutici S.p.A

Industry Sponsor

Trials

53

Recruited

4,400+

Founded

:[-1880s implied start, exact date not specified],

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania