Study on Reparixin for Patients with Myelofibrosis

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05835466

Provider View

This clinical trial is testing the safety and effectiveness of a drug called Reparixin in patients with certain types of myelofibrosis who have not responded to previous treatments or are unable to take a specific type of medication. The study involves taking Reparixin orally for a set period and monitoring its effects.

Patient Parameters

Program Overview

This study is designed to evaluate how well the drug Reparixin works in treating patients with myelofibrosis, a type of blood cancer. It is open to patients who have not had success with previous treatments or cannot take a medication called a Janus kinase inhibitor (JAKi). Participants will take Reparixin by mouth three times a day in 4-week cycles for a total of 6 cycles (24 weeks). If the disease is stable after this period, they may continue taking the drug once a day until the disease progresses or they experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to sign a consent form.
  • Must have a confirmed diagnosis of primary myelofibrosis or related conditions with a certain risk level.
  • Must be in good general health with a performance status score of 2 or less.
  • Must be willing to have a bone marrow biopsy.
  • Must have tried and not responded to or cannot take JAKi therapy.
  • Must have recovered from any side effects of previous treatments.
  • Must have stopped any other myelofibrosis treatments at least two weeks before starting the study.
  • Must have adequate organ function based on specific blood tests.
  • Must have a life expectancy of at least six months.
  • Women of childbearing potential and men must agree to use contraception during the study and for 120 days after.
  • Must be able to attend all study visits and follow the study requirements.

Exclusion Criteria

  • Cannot have used an experimental drug or device within four weeks before starting the study.
  • Cannot have had a stroke, heart attack, or serious heart issues in the last six months.
  • Cannot have had other cancers in the last three years, except for certain skin or localized cancers.
  • Cannot have serious heart disease or uncontrolled high blood pressure.
  • Cannot have a serious infection.
  • Cannot have a serious medical or psychiatric condition that would interfere with the study.
  • Cannot have had a bone marrow transplant within 100 days before starting the study.
  • Cannot have a known history of HIV or active hepatitis infections.
  • Cannot have digestive issues that affect drug absorption.
  • Cannot be related to anyone involved in the study's management.
  • Cannot have received an organ transplant other than bone marrow.
  • Cannot be pregnant or breastfeeding.

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