Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis

Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Study ID
NCT07750574
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myelofibrosis
  • Myelofibrosis (PMF)
  • Myelofibrosis Due to and Following Polycythemia Vera
  • Myelofibrosis Transformation in Essential Thrombocythemia
  • Myelofibrosis With High Molecular Risk Mutations
  • Myelofibrosis With Myeloid Metaplasia
  • Myelofibrosis, Post ET
  • Myelofibrosis, Post PV
  • Myelofibrosis, Primary
  • Myelofibrosis; Anemia
  • Myelofibrosis，MF
  • Myeloid Metaplasia

Eligibility Criteria

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

Interventions

  • Flonoltinib Maleate orally — DRUG
    Dose of Flonoltinib Maleate will be 50mg daily
  • Flonoltinib Maleate orally — DRUG
    Dose of Flonoltinib Maleate will be 75mg daily
  • Flonoltinib Maleate orally — DRUG
    Dose of Flonoltinib Maleate will be 100mg daily

Study Details

The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are: Which dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis. Participants will: Take Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis. Visit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study. Visit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy. Keep a diary of their symptoms.

Key Dates

First listed
Aug 6, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: 35 fully evaluable patients (14 JAKi-naïve - 21 JAKi-resistant) will receive Flonoltinib 50mg daily
    This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 50mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.
  • Experimental: 35 participants (14 JAKi-naïve, 21 JAKi-resistant) with MF will receive Flonoltinib 75mg daily
    This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 75mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.
  • Experimental: 35 fully evaluable patients (14 JAKi-naïve - 21 JAKi-resistant) will receive Flonoltinib 100mg daily
    This study arm will include 35 fully eligible and evaluable participants with myelofibrosis, including 14 JAKi-naïve and 63 JAKi-resistant, who are randomized to receive 100mg of oral Flonoltinib daily. Participants will receive continuous treatment until unacceptable toxicities, progressive disease or meeting other stopping criteria. The key safety endpoints and clinical efficacy endpoints will be evaluated at the end of 6 cycles (24 weeks). Other efficacy and safety evaluations will be conducted every 3 to 6 cycles. Safety follow-up will be conducted up to 30 days after the last dose and all participants will be followed up for adverse events, serious adverse events, and concomitant medication (including any new therapy) for 30 days following last Flonoltinib dose.

Primary Outcome Measure

Percentage of participants with ≥35% reduction in spleen volume as assessed by imaging from baseline to week 24 [ Time Frame: Baseline and at 24 weeks on study ]

Central Contacts

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