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Flunotinib Maleate Phase II Intermediate-High Risk Bone Fiber Clinical Trial

Study Purpose

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 fruquintinib maleate tablet group, high-dose fruquintinib maleate tablet group, or the ruxolitinib tablet group. Stratification factors include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - • Age ≥ 18 years, no gender restrictions; - Diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) according to IWG-MRT criteria; - Evaluated as intermediate-2 or high-risk myelofibrosis according to the Dynamic International Prognostic Scoring System (DIPSS) risk classification; - Expected survival greater than 24 weeks; - ECOG score of 0-2; - Splenomegaly: palpable spleen edge reaching or exceeding 5 cm below the costal margin (distance from the intersection of the left midclavicular line and the left costal margin to the farthest point of the spleen); or not palpable due to body habitus (obesity) but confirmed by MRI (or CT scan if necessary) at screening with spleen volume ≥ 450 cm³; - Peripheral blood and bone marrow blasts ≤ 10%; - Within 7 days before the first dose, ANC ≥ 1.0×10^9/L, platelet count ≥ 50×10^9/L, HGB > 60 g/L (participants should not have received growth factors, colony-stimulating factors, thrombopoietic agents, or platelet transfusions within 2 weeks before the baseline assessment prior to the first dose); - Major organ function basically normal within 7 days before the first dose; - Able to understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • - Previous anticancer treatment-related toxic reactions have not recovered to grade 1 or below (excluding alopecia and conditions specified in inclusion criteria 8 and 9), or have not fully recovered from previous surgery (major surgery within 4 weeks); - Hypersensitivity, allergic to the investigational drug or its excipients; - Previous intolerance or resistance to ruxolitinib; - Use of JAK inhibitors within 4 weeks before the first dose; - Any significant clinical and laboratory abnormalities that, in the investigator's opinion, affect safety evaluation; - History of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident (excluding lacunar infarction), or pulmonary embolism within 6 months prior to screening; - Impaired cardiac function or arrhythmic disease requiring treatment at screening; - Any active infection requiring intravenous antibiotic treatment at screening; - Active tuberculosis infection within 48 weeks prior to screening or latent tuberculosis infection indicated by tuberculosis-related tests during the screening period; - Patients who have undergone splenectomy or received radiation therapy to the spleen area within 12 months before the first dose; - Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, except for: a) HBV infection: Patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) with undetectable peripheral blood HBV-DNA (below the detection limit of the testing laboratory) can be enrolled; they must continue antiviral therapy and have HBV-DNA testing every 12 weeks and at the end of treatment (EOT); b) HCV seropositive patients with negative HCV RNA can be enrolled.
  • - Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab) (patients with positive Treponema pallidum antibody can have a titer test, and the investigator will determine eligibility based on comprehensive judgment); - Patients with epilepsy or those using psychiatric drugs or sedatives at screening (excluding those used for sleep purposes); - Pregnant or breastfeeding women, and patients with reproductive potential (male and female) who refuse to use contraceptive measures during the trial and for 6 months after the trial; - Patients who have had another malignancy within 5 years before the first dose (excluding cured in-situ carcinoma and basal cell carcinoma of the skin); - Patients with other severe diseases that, in the investigator's opinion, may affect safety or compliance; - Patients who participated in other clinical trials of new drugs or medical devices within 1 month before the first dose and used the investigational drug or device; - Use of any treatment for MF (other than JAK inhibitors) within 2 weeks or 5 half-lives (whichever is longer) before the first dose, any immunomodulatory agents (e.g., thalidomide), any immunosuppressants, ≥10 mg/day prednisone or equivalent biological potency corticosteroids, or growth factors (e.g., EPO) (Traditional Chinese medicine should be stopped 1 day before the first dose); - Patients with a history of congenital or acquired bleeding disorders; - Other factors that the investigator deems unsuitable for participation in the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06457425
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chengdu Zenitar Biomedical Technology Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhijian Xiao, Doctor\Y'99 Niu, Doctor
Principal Investigator Affiliation Hematology Hospital, Chinese Academy of Medical SciencesWest China Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

MF,PMF,PPV-MF,PET-MF
Arms & Interventions

Arms

Experimental: low dose group

Flonoltinib 50mg

Experimental: high dose group

Flonoltinib 100mg

Experimental: control subjects

Ruxolitinib

Interventions

Drug: - Flonoltinib 50mg

Flonoltinib 50mg

Drug: - Flonoltinib 100mg

Flonoltinib 100mg

Drug: - Ruxolitinib

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.

Contact a Trial Team

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International Sites

West China Hospital Sichuan University, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital Sichuan University

Chengdu, Sichuan, 610000

Site Contact

JingZe Zuo

[email protected]

028-85422654

Tianjin, Tianjin, China

Status

Recruiting

Address

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin, 300052

Site Contact

Qirou Wang, Doctor

[email protected]

022-23909095