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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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).

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Gecacitinib (also known as Jaktinib)

Treatment groups

39 Participants
are divided into 1 treatment group

Locations

This trial has no locations