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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
39
Gecacitinib 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.
Time frame: 1 year post-HSCT
Cumulative incidence of aGVHD
Cumulative incidence of grades II-IV and II-IV acute GVHD at +100 days and 6 months after HSCT
Time frame: +100 days and 6 months post-HSCT
Cumulative incidence of cGVHD
Cumulative incidence of moderate to severe chronic GVHD at 6 months and 1 year post-HSCT
Time frame: 6 months and 1 year post-HSCT
The molecular relapse rate of MF
The molecular relapse rate of MF at 1 year post-HSCT.
Time frame: 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.
Time frame: 6 months and 1 year post-HSCT
Rate of Engraftment
Engraftment is defined as the patient achieving peripheral blood neutrophil counts \>0.5×10⁹/L for three consecutive days and platelet counts \>20×10⁹/L for seven consecutive days, without the need for platelet transfusion.
Time frame: 100 days post-HSCT
Proportion of patients with baseline splenomegaly achieving a ≥35% reduction in spleen volume.
Proportion of patients with baseline splenomegaly (palpable spleen edge at or beyond at least 5 cm below the costal margin) achieving a ≥35% reduction from baseline in spleen volume.
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Time frame: 100 days, 6 months, and 1 year post-HSCT
Overall Survival
Overall survival is measured as the time from the hematopoietic stem cell transplantation (HSCT) until death. Participants without an event will be censored at the date of last contact.
Time frame: 1 year post-HSCT
Progression Free Survival (PFS)
PFS is defined as the time from the date of the first stem cell infusion until death from any cause, disease progression, or hematological relapse, whichever occurs first.
Time frame: 1 year post-HSCT
Toxicity rate
Cumulative incidence of treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0). Early deaths from all other causes are considered a competing risk.
Time frame: From the first dose to 28 days after the last dose.