NCT06388759终止1 期
A Phase Ib Study of TQ05105 Tablets for the Treatment of Intermediate and High Risk Myelofibrosis Refractory/Relapsed/Intolerant to Ruxolitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Spleen volume reduction (SVR35)≥35% from baseline
研究概览
简要总结
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects voluntarily participated in this study, signed informed consent forms, and demonstrated good compliance；
- •Age: 18 or older (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks;
- •Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF);
- •According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated;
- •Patients with poor efficacy or intolerant of Ruxolitinib;
- •Spleen enlargement;
- •Peripheral blood primary cells and bone marrow primary cells were ≤10%;
- •No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration;
- •The Main organ function is normal;
- •Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotrophin（HCG）test is not negative within 7 days before the first administration and must be non-lactating patients.
排除标准
- •Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
- •Previous treatment with JAK inhibitors(except ruxolitinib);
- •Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- •Other malignancies within 3 years prior to first administration or currently present;
- •Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
- •The non-hematological toxicity caused by previous treatment did not return to grade≤1;
- •Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
- •Presence of congenital bleeding disorder and congenital coagulopathy;
- •Patients who had arterial/venous thrombosis events within 6 months before the first administration;
- •Have a history of mental drug abuse, or have a mental disorder;
- •Active or uncontrolled severe infection;
- •Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV RNA positive;
- •Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia, QT interval prolongation and ≥ grade 2 congestive heart failure;
- •Unsatisfactory blood pressure control despite standard therapy;
- •Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- •Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
- •Patients with a history of immunodeficiency disease or organ transplantation;
- •Patients with epilepsy requiring treatment;
- •Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to first administration;
- •Patients who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first administration;
- •Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- •There was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period;
- •People with known hypersensitivity to the study drug and excipients;
- •Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
- •Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration;
- •According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.
研究组 & 干预措施
TQ05105 Tablets
Experimental
TQ05105 Tablets，28 days as a treatment cycle.
干预措施: TQ05105 Tablets (Drug)
结局指标
主要结局
Spleen volume reduction (SVR35)≥35% from baseline
时间窗: up to 24 weeks
The proportion of subjects with spleen volume reduction ≥35%from baseline at the end of treatment at week 24.
次要结局
- Optimum effective rate(up to 120 weeks)
- Onset time of splenic response(up to 120 weeks)
- The total symptom score of MPN-SAF TSS decreased compared with baseline(up to 120 weeks)
- Duration of maintenance of spleen response (DoMSR) ≥35% reduction(up to 120 weeks)
- Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline(up to 24 weeks)
- Progression-free survival (PFS)(up to 120 weeks)
- Severity of AEs(baseline up to 120 weeks)
- Leukemia free survival (LFS)(up to 120 weeks)
- Overall Survival (OS)(up to 120 weeks)
- Incidence of adverse events (AEs)(baseline up to 120 weeks)
研究者
研究点 (6)
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