Actively Recruiting
A Randomized, Open-label, Positive-controlled, Parallel-group, Multicenter Study on Flonoltinib Maleate Tablets in Patients with Intermediate- or High-risk Myelofibrosis
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-03-04
105
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Flonoltinib Maleate Tablets in adults with intermediate- or high-risk myelofibrosis, a type of bone marrow disorder. This Phase III clinical trial compares Flonoltinib with the active control drug Ruxolitinib Phosphate. Participants are assigned to one of the two groups based on their risk level using the Dynamic International Prognostic Scoring System (DIPSS). The study aims to measure how well these treatments reduce spleen size and improve symptoms over time. Participants take either Flonoltinib 75mg once daily or Ruxolitinib according to prescribed doses twice daily, both taken on an empty stomach. The trial is open-label and conducted at multiple centers, with approximately 105 participants planned for enrollment. Treatment continues until withdrawal criteria are met. The study includes evaluations at various time points up to 24 weeks, focusing on spleen volume reduction and symptom improvement. During the trial, participants undergo regular assessments including physical exams, spleen size measurements using MRI or CT scans, and symptom scoring using the MPN-SAF Total Symptom Score. Blood tests monitor organ function and safety. The primary outcome is the percentage of subjects achieving at least a 35% reduction in spleen volume at week 24. Secondary outcomes include time to spleen response, symptom score changes, and overall survival. Safety and laboratory tests are conducted throughout the study, which lasts several months from enrollment to final assessments.
CONDITIONS
Brief 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) per WHO 2016 criteria or post-polycythemia vera or post-thrombocytopenia myelofibrosis per IWG-MRT criteria
- Expected to survive longer than 24 weeks
- ECOG performance status score between 0 and 2
- Enlarged spleen: palpable 5 cm or more below the left rib or spleen volume ≥ 450 cm³ confirmed by MRI/CT
- Normal main organ function within 7 days before randomization, including specific liver enzymes and kidney function limits
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Toxic reactions from previous cancer treatments not recovered to grade 1 or below (except hair loss) or incomplete recovery from surgery
- Allergy to study drugs or their components
- Significant clinical or lab abnormalities affecting safety, including uncontrolled diabetes, uncontrolled hypertension, or peripheral neuropathy
- History of severe heart failure, unstable angina, recent heart attack, stroke, or thromboembolism within 6 months prior to screening
- Impaired cardiac function, abnormal heart rhythms requiring treatment, or abnormal ECG findings
- Bleeding disorders or unstable blood clotting conditions needing anticoagulant therapy
- Active infections requiring systemic treatment within 14 days before randomization
- Active hepatitis B or C infection except specific controlled cases
- Positive for HIV or syphilis antibodies
- Epilepsy or use of psychotropic or sedative drugs during screening
- Pregnant or breastfeeding, or unwilling to use birth control during and 6 months after the study
- History of other cancers within 5 years except certain cured skin cancers
- Difficulty swallowing
- Participation in other drug or device trials within 1 month prior to randomization
- 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 receive Flonoltinib Maleate Tablets or Ruxolitinib Phosphate as part of the study treatment.
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, 300052
Actively Recruiting
Research Team
W
Wang Fangmei
S
Sun Liangkun
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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