The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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;
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).
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.
Single group
Gecacitinib (also known as Jaktinib)
DrugGecacitinib treatment is initiated or continued at least two weeks before transplantation (Day -14) at a dose of 50 mg bid. This dose is maintained during preconditioning and the transplantation period until hematopoietic reconstitution, after which the dose is increased to 100 mg bid once platelet count recovers to ≥50×10⁹/L and absolute neutrophil count (ANC) recovers to ≥0.5×10⁹/L. The 100 mg bid dose is maintained until six months post-transplantation, after which it is adjusted to 50 mg bid until one year post-transplantation.
1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant
GRFS is defined as the absence of grade 3 to 4 acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, disease relapse, and death.
Cumulative incidence of aGVHD
Cumulative incidence of grades II-IV and II-IV acute GVHD at +100 days and 6 months after HSCT
Cumulative incidence of cGVHD
Cumulative incidence of moderate to severe chronic GVHD at 6 months and 1 year post-HSCT
The molecular relapse rate of MF
The molecular relapse rate of MF at 1 year post-HSCT.
Non-relapse mortality (NRM) rates
Non-relapse mortality (NRM) is defined as non-relapse death due to any cause without the recurrence or progression of myelofibrosis.
Changes in absolute counts of lymphocyte subsets
Assessment of changes in the absolute numbers (cells/µL) of major lymphocyte subsets in peripheral blood, including T cells (CD3+), helper T cells (CD3+CD4+), cytotoxic T cells (CD3+CD8+), B cells (CD19+), and natural killer (NK) cells (CD16+CD56+).
Changes in concentrations of immunoglobulins
Measurement of changes in the levels of serum immunoglobulins, including IgG, IgA, and IgM, reported in g/L.
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