Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.
研究概览
简要总结
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
详细描述
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •histological verification of malignancy at the time of initial diagnosis；
- •Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10^9/L；
- •patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
- •patients to have normal laboratory findings:while white blood count >3.0×10^9/L,platelet count ≥100×10^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
- •The estimated life expectancy of the patient was more than 3 months.
排除标准
- •patients who received total body irradiation；
- •patients with childbearing potential；
- •patients who were breast-feeding or pregnant
研究组 & 干预措施
A1
Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg).
Only for Dose-finding in Phase Ⅲa.
干预措施: NL201 (Drug)
A2
Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg).
Only for Dose-finding in Phase Ⅲa.
干预措施: NL201 (Drug)
A
Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg).
Only in Phase Ⅲb.
干预措施: NL201 (Drug)
A
Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg).
Only in Phase Ⅲb.
干预措施: rhIL-11 (Drug)
B
Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）.
Only in Phase Ⅲb.
干预措施: NL201 (Drug)
B
Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）.
Only in Phase Ⅲb.
干预措施: rhIL-11 (Drug)
结局指标
主要结局
Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.
时间窗: During 21 days of chemotherapy cycles
次要结局
- Platelet counts at day 21 after the initiation of chemotherapy.(Day 21 after the initiation of chemotherapy.)
- Average platelet counts(During 21 days of chemotherapy cycles)
- Nadir platelet counts(During 21 days of chemotherapy cycles)
- Incidence of thrombocytopenia(During 21 days of chemotherapy cycles)