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A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Primary completion moved earlier from May 6, 2026 to Nov 26, 2025
    • Study completion pushed from Jul 6, 2026 to May 12, 2027
    • Site details revised at 2 of 2 sites
    v3
  2. Primary endpoint revised
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 4 to 5
    • Study title expanded, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)
Trial Details
NCT Number NCT06457425
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 MF,PMF,PPV-MF,PET-MF
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov