Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06457425

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

Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2025-04-10

75

Participants Needed

2

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with no gender restrictions
  • Diagnosed with primary myelofibrosis (PMF) per WHO 2016 criteria or post-polycythemia vera or post-essential thrombocythemia myelofibrosis per IWG-MRT criteria
  • Evaluated as intermediate-2 or high-risk myelofibrosis by the Dynamic International Prognostic Scoring System (DIPSS)
  • Expected survival of at least 24 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Palpable spleen edge at least 5 cm below the left costal margin or confirmed spleen volume of 450 cm³ or more by MRI or CT scan
  • Blasts in peripheral blood and bone marrow 10% or less
  • Absolute neutrophil count at least 1.0 x 10^9/L, platelet count at least 50 x 10^9/L, hemoglobin over 60 g/L within 7 days before first dose
  • No recent use of growth factors, colony-stimulating factors, thrombopoietic agents, or platelet transfusions within 2 weeks before first dose
  • Major organ function basically normal within 7 days before first dose
  • Able to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Previous anticancer treatment toxic reactions not resolved to grade 1 or below or recent major surgery within 4 weeks
  • Allergy or hypersensitivity to investigational drug or its components
  • Previous intolerance or resistance to ruxolitinib
  • Use of JAK inhibitors within 4 weeks before first dose
  • Significant clinical or laboratory abnormalities affecting safety
  • History of heart failure, unstable angina, heart attack, stroke (excluding lacunar infarction), or pulmonary embolism within 6 months
  • Impaired cardiac function or arrhythmia requiring treatment at screening
  • Active infection requiring intravenous antibiotics at screening
  • Active or latent tuberculosis infection within past 48 weeks
  • Prior splenectomy or radiation to spleen area within 12 months
  • Active hepatitis B or C infection unless controlled
  • Positive HIV or syphilis test unless deemed eligible by investigator
  • Epilepsy or use of psychiatric drugs or sedatives (except for sleep aids)
  • Pregnant or breastfeeding women; patients refusing contraception during and 6 months after trial
  • Another malignancy within 5 years except certain skin or in-situ cancers
  • Other severe diseases affecting safety or compliance
  • Participation in other clinical trials within 1 month
  • Recent use of treatments for myelofibrosis (excluding JAK inhibitors), immunomodulatory agents, immunosuppressants, high-dose corticosteroids, or growth factors before first dose
  • History of bleeding disorders
  • Other factors deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

West China Hospital Sichuan University

Chengdu, Sichuan, China, 610000

Actively Recruiting

2

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China, 300052

Actively Recruiting

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Research Team

L

Liangkun Sun

CONTACT

Z

Zheng Jiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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