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

Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Study ID
NCT06457425
Phase
PHASE2
Status
Recruiting
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Conditions

  • MF,PMF,PPV-MF,PET-MF

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Flonoltinib 50mg — DRUG
    Flonoltinib 50mg, QD
  • Flonoltinib 100mg — DRUG
    Flonoltinib 100mg, QD
  • Ruxolitinib — DRUG
    For patients with platelet counts between 100×10\^9/L and 200×10\^9/L, the recommended starting dose is 15 mg twice daily (bid). For patients with platelet counts \>200×10\^9/L, the recommended starting dose is 20 mg bid. For patients with platelet counts between 50×10\^9/L and \<100×10\^9/L, the recommended maximum starting dose is 5 mg bid.

Study Details

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)

Key Dates

Start date
May 6, 2024
Status verified
Apr 2025
Primary completion
May 6, 2026
Completion
Jul 6, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: low dose group
    Flonoltinib 50mg
  • Experimental: high dose group
    Flonoltinib 100mg
  • Active Comparator: control group
    Ruxolitinib

Primary Outcome Measure

Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC) [ Time Frame: Week 24 ]

Central Contacts