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.
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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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