NCT06457425进行中（未招募）2 期
An Open-Label, Positive Drug-Controlled, Parallel, Multicenter Phase II Clinical Trial of the Efficacy, Safety, and Pharmacokinetics of Flonoltinib Maleate Tablets in Patients With Intermediate to High-Risk Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)
研究概览
简要总结
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)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥ 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 magnetic resonance imaging (MRI ) (or CT scan if necessary) at screening with spleen volume ≥ 450 cm³;
- •Blasts in peripheral blood and bone marrow ≤ 10%; 8) Within 7 days before the first dose, absolute absolute neutrophil count (ANC )≥ 1.0×10^9/L, platelet count ≥ 50×10^9/L, hemoglobin (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); 9) Major organ function basically normal within 7 days before the first dose; 10) Able to understand and voluntarily sign the informed consent form.
排除标准
- •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 investigational 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., erythropoietin (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.
研究组 & 干预措施
high dose group
Experimental
Flonoltinib 100mg
干预措施: Flonoltinib 100mg (Drug)
low dose group
Experimental
Flonoltinib 50mg
干预措施: Flonoltinib 50mg (Drug)
control group
Active Comparator
Ruxolitinib
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)
时间窗: Week 24
Percentage of subjects with ≥35% reduction in spleen volume from baseline(Evaluation by IRC)
次要结局
- Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)(Week 12)
- Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by IRC)(Week 12)
- Percentage of subjects with ≥50% reduction in MPN-SAF TSS scale total symptom score(Week 24 and Week 12)
- Objective response rate (ORR = CR + PR) per the IWG-MRT consensus criteria.(Week 24)
- Percentage of subjects with ≥35% reduction in spleen volume from baseline (Evaluation by researcher)(Week 24)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT03316781Shanghai Henlius Biotech262
已完成
不适用
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DMType 2 Diabetes MellitusNCT05417841Beijing Hospital218
招募中
3 期
A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 DiabetesType 2 DiabetesNCT04955834Chia Tai Tianqing Pharmaceutical Group Co., Ltd.344
尚未招募
3 期
A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese SubjectsObesityNCT06738979Chia Tai Tianqing Pharmaceutical Group Co., Ltd.408
已完成
4 期
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination TherapyType 2 Diabetes MellitusNCT01444248Handok Inc.168