Actively Recruiting
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-03-04
105
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.
CONDITIONS
Official Title
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old, any gender
- Diagnosed with primary myelofibrosis (PMF) according to WHO 2016 or post-polycythemia vera or post-thrombocytopenia myelofibrosis per IWG-MRT criteria
- Expected survival longer than 24 weeks
- ECOG performance status score between 0 and 2
- Enlarged spleen palpable at 5 cm or more below the left rib or spleen volume ≥450 cm³ by MRI/CT
- Normal main organ function within 7 days before randomization (ALT and AST ≤2.5× ULN; total bilirubin ≤2.0× ULN; serum creatinine ≤1.5× ULN or creatinine clearance >50 mL/min; INR, PT, and APTT ≤1.5× ULN)
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Toxic reactions from prior anti-cancer treatments not recovered to grade 1 or less (except hair loss) or incomplete recovery from surgery
- Allergy to study drugs or their ingredients
- Significant clinical or lab abnormalities affecting safety, such as uncontrolled diabetes (fasting glucose >250 mg/dL), uncontrolled hypertension despite treatment, or peripheral neuropathy
- History of severe heart failure (NYHA III+), unstable angina, recent heart attack, stroke, or blood clots within 6 months
- Impaired heart function (ejection fraction <45%, arrhythmias needing treatment, prolonged QTcF on ECG)
- Bleeding disorders or unstable blood clotting requiring anticoagulant therapy
- Active infection requiring systemic treatment within 14 days before randomization
- Active hepatitis B or C infections except certain controlled cases
- Positive for HIV or syphilis antibodies
- Epilepsy or use of psychotropic or sedative drugs during screening
- Pregnant or breastfeeding women or those refusing contraception during study and 6 months after
- Other cancers within 5 years except certain skin or in situ cancers
- Difficulty swallowing
- Participation in other clinical trials of new drugs or devices within 1 month before randomization
- Other factors deemed unsuitable by researchers
AI-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, 300052
Actively Recruiting
Research Team
W
Wang Fangmei
CONTACT
S
Sun Liangkun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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