NCT07925671Not yet recruiting
Jaktinib in Ruxolitinib-Treatment Failure Myelofibrosis: A Multicenter, Prospective, Real-World Observational Study
A Multicenter, Prospective, Real-World Observational Study to Evaluate the Efficacy and Safety of Jaktinib in Patients With Myelofibrosis and Ruxolitinib Treatment Failure
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
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.
- 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
- NCT07925671
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 myelofibrosis whose earlier ruxolitinib treatment did not work, stopped working, or was not tolerated, and who start or already take jaktinib next.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Ruxolitinib must have failed: little or no spleen shrinkage, spleen regrowth after an initial response, or intolerance (still needing red blood cell transfusions or grade 3 or higher anemia, low platelets or bleeding).
- Earlier treatment
- Must have had ruxolitinib (at least 3 months for refractory or relapsed disease, at least 28 days for intolerance). Jaktinib is the planned or current next treatment. No other JAK inhibitors such as fedratinib, pacritinib or momelotinib.
Main reasons for not taking part
- Other JAK inhibitors besides ruxolitinib and jaktinib (for example fedratinib, pacritinib, momelotinib)
- Earlier other blood cancers or active solid tumors within the past 5 years
- Earlier donor stem cell transplant
- Severe liver or kidney problems
- Active uncontrolled infection (including HIV, hepatitis B/C or tuberculosis), or pregnant or breastfeeding
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
- 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).
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 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.
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.
- 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.
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.