Jaktinib for Myelofibrosis After Ruxolitinib Treatment Has Failed

Trial details

Who runs it

Affiliated Hospital of Nantong University

Trial code

NCT07925671

Record updated

9 November 2026

Original description

This is a multicenter, prospective, real-world observational study designed to evaluate the efficacy and safety of jaktinib in patients with myelofibrosis (MF) who have failed ruxolitinib treatment (including refractory, relapsed, or intolerant cases). The primary outcome measure is the proportion of patients achieving anemia response at week 24. Secondary outcome measures include MF-related symptom response rate (≥50% reduction in total symptom score, TSS50) at week 24, spleen volume reduction ≥35% (SVR35) at week 24, progression-free survival (PFS), leukemia-free survival (LFS), overall survival (OS), and safety/tolerability. This study will provide real-world evidence to support the use of jaktinib as a valuable treatment option for MF patients with ruxolitinib failure, a population with limited therapeutic alternatives.Read full original descriptionShow less

A Multicenter, Prospective, Real-World Observational Study to Evaluate the Efficacy and Safety of Jaktinib in Patients With Myelofibrosis and Ruxolitinib Treatment Failure

This is a multicenter, prospective, real-world observational study designed to evaluate the efficacy and safety of jaktinib in patients with myelofibrosis (MF) who have failed ruxolitinib treatment (including refractory, relapsed, or intolerant cases). The primary outcome measure is the proportion of patients achieving anemia response at week 24. Secondary outcome measures include MF-related symptom response rate (≥50% reduction in total symptom score, TSS50) at week 24, spleen volume reduction ≥35% (SVR35) at week 24, progression-free survival (PFS), leukemia-free survival (LFS), overall survival (OS), and safety/tolerability. This study will provide real-world evidence to support the use of jaktinib as a valuable treatment option for MF patients with ruxolitinib failure, a population with limited therapeutic alternatives.

Inclusion: Patients with a confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the 2022 World Health Organization (WHO) and modified International Working Group for Myelofibrosis Research and Treatment criteria; Age ≥ 18 years at the time of Jaktinib initiation; Patients must belong to one of the following three cohorts:; Refractory MF is defined as a condition where, after being treated with ruxolitinib for ≥3 months, the spleen volume was reduced by <10% as assessed by the magnetic resonance imaging (MRI)/computed tomography (CT), or < 30% in spleen size by palpation compared with the baseline mea- surement; Relapsed MF is defined as a situation where after receiving ruxolitinib treatment for ≥3 months, there is a spleen regrowth (SVR <10% by MRI/CT, or <30% in spleen size by palpation from the base- line measurement), following an initial spleen response; Ruxolitinib intolerant is defined as patients who have received or are receiving ruxolitinib treatment for no less than 28 days and have at least one of the following conditions during its treatment: RBC transfusions still required or increased in frequency; grade 3 or higher anemia, thrombocytopenia, and hematoma and/or hemorrhage occurred; Planned to receive or currently receiving Jaktinib as the next line of therapy after ruxolitinib failure; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Willing and able to comply with the study protocol and scheduled follow-up assessments; Patients who have provided written informed consent for the use of their clinical data in this prospective clinical study.

Exclusion: Patients who have received JAK inhibitors other than ruxolitinib and Jaktinib (e.g., fedratinib, pacritinib, momelotinib) prior to or during the study period; Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT); Patients with a history of other hematologic malignancies (e.g., acute leukemia, myelodysplastic syndrome) or active solid tumors within the past 5 years; Patients with active, uncontrolled infections (including HIV, active hepatitis B/C, or tuberculosis) at the time of Jaktinib initiation; Patients with clinically significant cardiovascular, pulmonary, or other systemic diseases that, in the investigator's judgment, may interfere with the evaluation of efficacy or safety; Patients with severe hepatic impairment, defined as Child-Pugh class C liver cirrhosis, or severe renal dysfunction, defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² at baseline; Patients with incomplete or missing key baseline clinical data (e.g., missing spleen size assessment, symptom scores, or laboratory results) that preclude evaluation of efficacy or safety; Pregnant or lactating women; Patients who do not provide or have not signed the informed consent form (ICF), or who have explicitly declined participation in this study.

ClinicalTrials.gov NCT07925671