Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis

Exclusion Criteria

• •1. Patients using other JAK inhibitors (except for Gecacitinib) at the time of screening may be enrolled if they switch to Gecacitinib treatment prior to screening.
• •2. Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
• •3. Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).
• •4. Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
• •1. Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or documented history of diastolic or systolic dysfunction (e.g., LVEF \<40% measured by echocardiography), or uncontrolled or unstable angina or myocardial infarction.
• •2. Uncontrolled diabetes (\>250 mg/dL or \>13.9 mmol/L).
• •3. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg).
• •4. Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).
• •5. Serum creatinine \>1.5 × ULN.
• •6. ALT or AST \>2.5 × ULN, or DBIL or TBIL \>2.0 × ULN.
• •5. Patients with any bacterial, viral, or fungal infection not adequately controlled.
• •6. HIV-positive at screening, or active hepatitis B virus infection (HBsAg-positive with HBV-DNA positivity or above the normal reference range), or HCV antibody-positive with HCV-RNA positivity.
• •7. History of tuberculosis or positive interferon-gamma release assay at screening.
• •8. Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.
• •9. Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.
• •10. Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.
• •11. Patients unable to take oral tablets.