Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gecacitinib treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gecacitinib (also known as Jaktinib) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year post-HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of aGVHD | Cumulative incidence of grades II-IV and II-IV acute GVHD at +100 days and 6 months after HSCT | +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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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+). | 3 months, 6 months, and 1 year. |
Inclusion Criteria:
Exclusion Criteria:
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).
Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
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.
Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.
Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.
Patients unable to take oral tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 months and 1 year post-HSCT |
| The molecular relapse rate of MF | The molecular relapse rate of MF at 1 year post-HSCT. | 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. | 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. | 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. | 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. | 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. | 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. | From the first dose to 28 days after the last dose. |
| Changes in concentrations of immunoglobulins |
Measurement of changes in the levels of serum immunoglobulins, including IgG, IgA, and IgM, reported in g/L. |
| 3 months, 6 months, and 1 year |