Study on Using Fedratinib to Prevent Cancer Relapse After Transplant in Patients with Myeloproliferative Neoplasms

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05127174

This clinical trial is testing whether the drug fedratinib can safely and effectively prevent cancer from returning in patients with myeloproliferative neoplasms (MPNs) after they have received a stem cell transplant.

Patient Parameters

Program Overview

The aim of this study is to see if fedratinib can help stop cancer from coming back in patients with myeloproliferative neoplasms (MPNs) who have had a stem cell transplant. Researchers will evaluate both the safety and effectiveness of using fedratinib as a maintenance therapy after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Be at least 18 years old.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Understand and agree to sign a consent form before any study procedures.
  • Be willing to follow the study schedule and requirements.
  • Have a specific type of blood cancer (Philadelphia chromosome negative myeloproliferative disease) and have undergone a first stem cell transplant.
  • Have successful engraftment, meaning the donor cells have taken hold, with specific blood cell counts.
  • No signs of cancer progression based on specific criteria.
  • If you have skin-related graft-versus-host disease (GVHD), it must be controlled with low-dose prednisone.
  • Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days after.
  • Men must agree to use a condom during sexual contact with women who can become pregnant and for 30 days after stopping the study drug.

Exclusion Criteria

  • Have active gut or liver GVHD requiring treatment.
  • Have used a JAK2 inhibitor within 14 days before joining the study.
  • Have certain abnormal lab results.
  • Be pregnant or breastfeeding.
  • Have a history of Wernicke's encephalopathy or symptoms of it.
  • Be taking medications that strongly affect the liver enzyme CYP3A4.
  • Have low thiamine levels that are not corrected before starting the study drug.
  • Be on certain cancer treatments or medications like aspirin over 150 mg daily.
  • Have had major surgery within 28 days before starting the study drug.
  • Have chronic liver disease or uncontrolled heart failure.
  • Have active HIV, Hepatitis B, or Hepatitis C infections.
  • Have a serious active infection.
  • Have a condition that affects the absorption of oral medication.
  • Have another active cancer requiring treatment, except for certain skin cancers.
  • Have more than 10% bone marrow blasts.
  • Be unable to swallow capsules.

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