Actively Recruiting
A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-05-13
64
Participants Needed
2
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the moderate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Select successful trial participants and allocate flonoltinib maleate tablets based on platelet count levels during the screening period, qd,Oral administration on an empty stomach until the participants meet the withdrawal criteria.
CONDITIONS
Official Title
A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosed with primary myelofibrosis (PMF) per WHO 2016 criteria, or post-polycythemia vera myelofibrosis (PPV-MF) or post-thrombocytopenia myelofibrosis (PET-MF) per IWG-MRT criteria
- Classified as intermediate-2 or high-risk by DIPSS, or intermediate-1 with hepatosplenomegaly needing treatment
- Previously treated with JAK inhibitors and are refractory, relapsed, or intolerant
- Expected survival longer than 24 weeks
- ECOG performance status score of 0 to 2
- Enlarged spleen palpable at 5 cm or more below the rib or spleen volume of >=450 cm³ by MRI/CT
- Peripheral blood and bone marrow blasts at 10% or less
- Within 7 days before randomization: ANC >=1.0 x10^9/L, platelet count >=100 x10^9/L, hemoglobin >60 g/L
- Normal main organ functions within 7 days before randomization: ALT and AST <= 2.5x ULN; total bilirubin <= 2.0x ULN; serum creatinine <= 1.5x ULN or creatinine clearance >50 mL/min; INR, PT, and APTT <= 1.5x ULN
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Toxic reactions from previous anticancer treatments not recovered to grade 1 or below (excluding hair loss), or recent major surgery within 4 weeks
- Allergy to the study drug or its components
- Significant clinical or lab abnormalities affecting safety, including uncontrolled diabetes (fasting glucose >250 mg/dL), uncontrolled hypertension despite treatment, or peripheral neuropathy
- History of congestive heart failure (NYHA grade III or above), unstable angina, heart attack, stroke, or blood clots within 6 months
- Impaired heart function (ejection fraction <45%, congenital arrhythmia, prolonged QTcF, or arrhythmia requiring treatment)
- Bleeding disorders or unstable clotting diseases needing anticoagulants
- Any active infection requiring systemic treatment within 14 days before enrollment
- Active or latent tuberculosis infections without completed preventive treatment
- Previous splenectomy or splenic radiation within 12 months
- Active hepatitis B or C infections unless meeting specific controlled conditions
- Positive HIV or syphilis antibody tests
- Epilepsy or use of psychotropic or sedative drugs during screening
- Pregnant or breastfeeding women, or those refusing contraception during and 6 months after the trial
- Other cancers within past 5 years except certain cured skin or carcinoma in situ cancers
- Swallowing, absorption, or chronic diarrhea issues
- Serious illnesses affecting safety or compliance
- Participation in other drug or device trials within 1 month before first dose
- Use of JAK inhibitors within 4 weeks or 5 half-lives before trial
- Use of other MF drugs, immunomodulators, immunosuppressants, or high-dose steroids within 2 weeks or 5 half-lives before screening
- Other factors judged unsuitable by researchers for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
West China Hospital Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
2
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
W
Wang Fangmei
CONTACT
S
Sun Liangkun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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