Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Platelet response at Week 2 (PLT ≥ 50×10⁹/L)
研究概览
简要总结
Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia
详细描述
Cancer treatment-induced thrombocytopenia (CTIT) refers to a decrease in platelet count caused by antitumor therapies during cancer treatment. It is a common adverse effect of anticancer treatment, with a particularly high incidence in patients with hematologic malignancies. CTIT increases the risk of bleeding, may limit treatment options, and can ultimately compromise the effectiveness of cancer therapy and reduce long-term survival. Currently, aside from platelet transfusion, thrombopoietic agents are commonly used to manage CTIT. Studies have shown that Romiplostim demonstrates a response rate of up to 71% in patients with chemotherapy-induced thrombocytopenia from solid tumors, with 89% of patients avoiding the need for platelet transfusion, thereby significantly reducing the risk of bleeding. However, there is limited evidence and a lack of prospective clinical trials investigating the use of Romiplostim in leukemia patients with CTIT. This study aims to evaluate the efficacy and safety of Romiplostim in adult leukemia patients with CTIT, in order to provide new therapeutic options and strategies, and ultimately improve the quality of life for this patient population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years, inclusive, regardless of sex;
- •Histologically or pathologically confirmed diagnosis of leukemia;
- •Patients with cancer treatment-induced thrombocytopenia (CTIT) in patients with leukemia due to antitumor therapy, with platelet count < 50×10⁹/L;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •Subjects of childbearing potential agree to use reliable methods of contraception throughout the study period (including male or female condoms, contraceptive foam, gel, film, cream, suppository, abstinence, or intrauterine device);
- •Patients considered by the investigator to potentially benefit from the study treatment;
- •Voluntarily agrees to participate in the clinical trial, is fully informed of the study procedures, and has signed the written informed consent form.
排除标准
- •Pregnant or breastfeeding women;
- •Known hypersensitivity to Romiplostim N01;
- •Presence of hematologic disorders other than cancer treatment-induced thrombocytopenia (CTIT) caused by leukemia treatment, including but not limited to primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;
- •History of thrombocytopenia due to causes other than CTIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infections, or bleeding disorders;
- •History of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy;
- •Severe bleeding within 2 weeks prior to screening (requiring more than 2 units of red blood cell transfusion or a sudden ≥10% drop in hematocrit);
- •Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 1 month prior to screening;
- •HIV infection;
- •Chronic active hepatitis B or hepatitis C infection;
- •Presence of severe infection or serious comorbidities involving the heart, liver, lungs, kidneys, nervous system, or metabolic diseases;
- •Participation in any investigational drug or device clinical trial within 28 days prior to baseline visit;
- •Subjects with cognitive impairment or uncontrolled psychiatric disorders;
- •Refusal of the subject and/or legal representative to receive Romiplostim N01 treatment;
- •Deemed unsuitable for enrollment by the investigator (e.g., comorbid conditions that may compromise subject safety or anticipated treatment non-adherence due to financial or other constraints).
研究组 & 干预措施
Romiplostim N01
Romiplostim N01 will be administered once weekly via subcutaneous injection upon the occurrence of Grade 3 thrombocytopenia (platelet count < 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. A maximum of 8 doses may be administered during the treatment period.
干预措施: Romiplostim N01 (Drug)
结局指标
主要结局
Platelet response at Week 2 (PLT ≥ 50×10⁹/L)
时间窗: 2 weeks
Proportion of patients achieving a platelet count ≥ 50×10⁹/L at 2 weeks after initiation of treatment.
次要结局
- Early Platelet Response Rate (within 7 days)(7 days)
- Median time to platelet recovery without transfusion(8 weeks)
- Total platelet transfusion during treatment(8 weeks)
- Platelet nadir during treatment(8 weeks)