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

Korábbi kezelés

• 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.
• Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
• Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).

Más betegség

• Patients with any bacterial, viral, or fungal infection not adequately controlled.
• 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.
• History of tuberculosis or positive interferon-gamma release assay at screening.
• Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.
• Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.

Laborértékek

• Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
  • 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.
  • Uncontrolled diabetes (\>250 mg/dL or \>13.9 mmol/L).
  • Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg).
  • Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).
  • Serum creatinine \>1.5 × ULN.
  • ALT or AST \>2.5 × ULN, or DBIL or TBIL \>2.0 × ULN.

Egyéb

• Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.
• Patients unable to take oral tablets.

• Aged 18-75 years, regardless of gender;
• Diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV-MF), or post-essential thrombocythemia myelofibrosis (post-ET-MF) according to the 2022 WHO diagnostic criteria;
• Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;
• Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;
• ECOG performance status ≤2 and Karnofsky performance status ≥60%;
• Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures.