NCT07925632Not yet recruiting
A Multicenter, Prospective, Observational Study of Jaktinib in Newly Diagnosed Myelofibrosis
Efficacy and Safety of Jaktinib in Newly Diagnosed Myelofibrosis: A Multicenter, Prospective, Real-World Observational Study
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 4 Nov 2026
- Start date
- 10 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07925632
What you commit to
- Study type: Observational
- Planned participants: 80
- From 10 Nov 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed myelofibrosis who have never had a JAK inhibitor and are starting jaktinib as their first treatment.
- Age
- 18 years or older when jaktinib is started.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
- Earlier treatment
- No earlier JAK inhibitor treatment of any kind. Jaktinib is the first treatment.
Main reasons for not taking part
- Earlier treatment with any JAK inhibitor
- Another blood cancer or an active solid tumour in the past 5 years
- Severe liver disease (Child-Pugh class C) or eGFR below 30 mL/min/1.73 m²
- Active uncontrolled infection, including HIV, active hepatitis B or C, or tuberculosis
- Pregnant or breastfeeding women
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any JAK inhibitor (including ruxolitinib, fedratinib, pacritinib, momelotinib, or others).
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University | Nantong | China | Unknown status |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.