Actively Recruiting
Flonoltinib Maleate for Treatment of Intermediate- or High-risk Myelofibrosis Patients Who Are Refractory, Relapsed, or Intolerant to JAK Inhibitors An Open-label, Multicenter Phase IIb Clinical Trial
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-05-13
64
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating flonoltinib maleate tablets in adult patients with intermediate to high-risk myelofibrosis (MF) who are refractory, relapsed, or intolerant to JAK inhibitors. This single-arm, open-label, multicenter phase IIb clinical trial aims to assess the safety and efficacy of this treatment in patients who have limited options after prior JAK inhibitor therapy. Participants will receive flonoltinib maleate tablets orally once daily on an empty stomach. The dose, either 50mg or 75mg, is assigned based on platelet counts measured during the screening period. Treatment continues until participants meet withdrawal criteria. The study includes approximately 64 participants and focuses on those with splenomegaly and specific blood count and organ function criteria. During the study, participants will be monitored regularly for spleen volume reduction, symptom improvement using the MPN-SAF TSS score, and overall survival over 24 weeks. Safety and organ function tests, including blood counts and liver and kidney function, will be performed. Researchers will track treatment effects and side effects throughout the trial duration, with all assessments planned at various time points including weeks 2, 4, 8, 12, and 24.
CONDITIONS
Brief 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 18 to 80 years old
- Diagnosed with primary myelofibrosis or post polycythemia vera or post thrombocytopenia myelofibrosis
- Intermediate-2 or high-risk myelofibrosis by DIPSS, or intermediate-1 myelofibrosis with hepatosplenomegaly requiring treatment
- Previously treated with JAK inhibitors and refractory, relapsed, or intolerant
- Expected survival longer than 24 weeks
- ECOG performance status 0-2
- Splenomegaly with spleen palpable at least 5cm below rib or spleen volume ≥450 cm³ by MRI/CT
- Peripheral blood and bone marrow blasts ≤10%
- ANC ≥1.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin >60 g/L within 7 days before randomization
- Normal liver, kidney, and coagulation function within 7 days before randomization
- Able to understand and sign informed consent
You will not qualify if you...
- Unresolved toxic reactions above grade 1 from prior cancer treatments or recent major surgery within 4 weeks
- Allergy to study drug or ingredients
- Significant clinical or lab abnormalities affecting safety, including uncontrolled diabetes, high blood pressure despite treatment, or peripheral neuropathy
- History of serious heart failure, unstable angina, recent heart attack, stroke, or blood clots within 6 months
- Impaired cardiac function including low ejection fraction, arrhythmias, or prolonged QT interval
- Bleeding disorders or unstable clotting conditions needing anticoagulants
- Active infections needing systemic treatment within 14 days
- Recent or latent tuberculosis infection without completed preventive treatment
- Previous spleen removal or splenic radiation within past 12 months
- Active hepatitis B or C infection not meeting specified criteria
- Positive HIV or syphilis antibodies
- Epilepsy or use of sedatives during screening
- Pregnant or breastfeeding, or unwilling to use contraception during and 6 months after trial
- Other cancers within past 5 years except certain skin cancers
- Swallowing or absorption disorders
- Other serious illnesses affecting safety or compliance
- Participation in other clinical trials within 1 month
- Recent use of JAK inhibitors or other MF drugs within specified timeframes
- Any other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants take flonoltinib maleate tablets 50mg or 75mg once daily on an empty stomach based on platelet count levels determined during screening.
Visits at Week 2, Week 4, Week 8, Week 12, and Week 24
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
S
Sun Liangkun
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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