NCT07317700招募中3 期
A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Percentage of subjects with >=35% reduction in spleen volume from baseline
研究概览
简要总结
This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of 18-80 years old , gender not limited;
- •Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF) according to IWG-MRT criteria;
- •Expected survival period greater than 24 weeks;
- •ECOG score 0-2 points;
- •Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib ; Or due to physical reasons (such as obesity), it may not be palpable, but MRI/CT spleen evaluation during screening confirms a volume of >= 450 cm^3;
- •Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST <= 2.5 × ULN; TBIL<=2.0×ULN； Serum creatinine <=1.5 × ULN or serum creatinine clearance rate (Ccr)>50 mL/min; INR, PT, and APTT <= 1.5 × ULN;
- •Can understand and voluntarily sign an informed consent form.
排除标准
- •The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries;
- •Allergy to experimental drugs and their excipients;
- •For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose>250 mg/dL (13.9 mmol/L), b. hypertension and cannot be reduced to the following range after treatment with two or more antihypertensive drugs (systolic blood pressure<160 mmHg, diastolic blood pressure<100 mmHg), c. peripheral neuropathy;
- •Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;
- •Individuals with impaired cardiac function (those with ejection fraction<45% detected by echocardiography, congenital ventricular arrhythmia, QTcF>450 ms on electrocardiogram (males), QTcF>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of screening);
- •Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
- •Any active infection requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within the first 14 days of randomization;
- •Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and undergo peripheral blood HBV-DNA testing, with the lower limit of HBV-DNA detection value (i.e. the upper limit of normal value in the laboratory of each research center) can be enrolled; If the baseline HBsAg is positive, continuous antiviral treatment is required after enrollment, and HBV-DNA testing should be conducted every 12 weeks and at EOT visits; b) Patients who are positive for HCV serology but negative for HCV-RNA can be included in the study;
- •Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);
- •Patients with epilepsy or those taking psychotropic or sedative drugs during screening;
- •Pregnant or lactating female patients, female/male patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;
- •Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
- •Patients with combined swallowing difficulties;
- •Patients who participated in clinical trials of other new drugs or medical devices within the first month of randomization and took the study drug or used the study device;
- •Researchers believe that there are other factors that are not suitable for participating in the experiment.
研究组 & 干预措施
Experimental group
Experimental
Flonoltinib Maleate Tablets 75mg, taken orally, qd
干预措施: Flonoltinib 75mg (Drug)
control group
Active Comparator
The dosage of Ruxolitinib Phosphate Tablets is based on baseline PLT level according to the label, taken orally, bid
干预措施: Ruxolitinib Phosphate (Drug)
结局指标
主要结局
Percentage of subjects with >=35% reduction in spleen volume from baseline
时间窗: Week 24
次要结局
- Spleen response time: The time when the spleen volume is first observed to decrease by >=35% from baseline(Week 12,week 24)
- Overall survival period(Week 2,week 4,week 8,week 12,week 24)
- MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease(Week 2,week 4,week 8,week 12,week 24)
研究者
研究点 (2)
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