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Studies jaktinib in adults newly diagnosed with myelofibrosis

Observes how jaktinib works and is tolerated in newly diagnosed myelofibrosis patients.

Plain-language title generated from the registry record
Registry title: A Multicenter, Prospective, Observational Study of Jaktinib in Newly Diagnosed Myelofibrosis

Key facts

Where
Nantong, ChinaSee the site

Where in China

  • Affiliated Hospital of Nantong UniversityNantong, ChinaNo longer taking part

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Trial details

Who runs it
Affiliated Hospital of Nantong University
Trial code
NCT07925632
Record updated
9 November 2026
Original description
This is a multicenter, prospective, observational clinical study designed to evaluate the real-world efficacy and safety of jaktinib in patients with newly diagnosed myelofibrosis (MF). The primary outcome measure is the proportion of patients achieving anemia response at week 24. Secondary outcome measures include MF-related symptom response rate (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 supporting the use of jaktinib as a first-line treatment for newly diagnosed MF patients.Read full original descriptionShow less

Efficacy and Safety of Jaktinib in Newly Diagnosed Myelofibrosis: A Multicenter, Prospective, Real-World Observational Study

This is a multicenter, prospective, observational clinical study designed to evaluate the real-world efficacy and safety of jaktinib in patients with newly diagnosed myelofibrosis (MF). The primary outcome measure is the proportion of patients achieving anemia response at week 24. Secondary outcome measures include MF-related symptom response rate (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 supporting the use of jaktinib as a first-line treatment for newly diagnosed MF patients.

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; Newly diagnosed MF: Patients who have not received prior JAK inhibitor therapy and are initiated on Jaktinib as first-line treatment; 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 observational study.

Exclusion: Prior treatment with any JAK inhibitor (including ruxolitinib, fedratinib, pacritinib, momelotinib, or others); 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 or renal dysfunction, defined as Child-Pugh class C liver cirrhosis or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² at baseline; 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 NCT07925632