Not Yet RecruitingPhase 2

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

39 participantsStarted 2026-03-16

Plain-language summary

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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

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:
✕. 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).

What they're measuring

1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant

Timeframe: 1 year post-HSCT

Trial details

NCT IDNCT07471503

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

View on ClinicalTrials.gov More Myelofibrosis (MF) trials