Study on Fedratinib for Treating Myelodysplastic/Myeloproliferative Neoplasms and Chronic Neutrophilic Leukemia

Inclusion Criteria

• Must understand and voluntarily sign a consent form before any study-related procedures.
• Must be 18 years or older.
• Must have a confirmed diagnosis of one of the following conditions:
  • Atypical Chronic Myeloid Leukemia (aCML), BCR-ABL1 negative
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable (MDS/MPN-U)
  • Myelodysplastic Syndrome/Myeloproliferative Neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
  • Chronic Neutrophilic Leukemia (CNL)
• Must have an enlarged spleen or specific symptoms related to the condition.
• Must have a performance status score of 0, 1, or 2, indicating good overall health.
• Must be able to follow the study schedule and requirements.
• 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 the last dose.
• Men must agree to use effective birth control during the study and for 90 days after the last dose and not donate sperm during this time.

Exclusion Criteria

• Have certain abnormal lab results as specified in the study.
• Are pregnant or breastfeeding.
• Are not using effective birth control if you or your partner can become pregnant.
• Have a history of or current symptoms of brain disorders like Wernicke's Encephalopathy.
• Are taking certain medications that affect liver enzymes or are on specific treatments like chemotherapy or high-dose steroids.
• Have previously taken fedratinib.
• Are taking certain medications like aspirin at high doses.
• Have chronic liver disease or active second cancers.
• Have uncontrolled heart failure or certain infections like HIV, Hepatitis B, or Hepatitis C, unless under control.
• Have a serious active infection needing IV antibiotics.
• Have digestive issues that prevent absorbing oral medication or cannot swallow capsules.
• Have participated in another study within 30 days before starting fedratinib.
• Have any condition that poses a risk or affects the study results.
• Have had major surgery or radiation therapy within four weeks before the study.