A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,231
- 试验地点
- 2
- 主要终点
- Bone marrow suppression and liver toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of marrow suppression with 2 methods of maintenance treatment in children with acute lymphoblastic leukemia.
- Compare the incidence of liver toxicity with 2 methods of maintenance treatment in these patients.
Secondary
- Determine any difference in infection rates and related hospitalizations in these patients.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard- or Intermediate-Risk Maintenance Arm I
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
干预措施: dexamethasone (Drug)
Standard- or Intermediate-Risk Maintenance Arm I
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
干预措施: mercaptopurine (Drug)
Standard- or Intermediate-Risk Maintenance Arm I
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
干预措施: methotrexate (Drug)
Standard- or Intermediate-Risk Maintenance Arm I
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
干预措施: vincristine sulfate (Drug)
Standard- or Intermediate-Risk Maintenance Arm II
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
干预措施: dexamethasone (Drug)
Standard- or Intermediate-Risk Maintenance Arm II
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
干预措施: mercaptopurine (Drug)
Standard- or Intermediate-Risk Maintenance Arm II
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
干预措施: methotrexate (Drug)
Standard- or Intermediate-Risk Maintenance Arm II
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Bone marrow suppression and liver toxicity
时间窗: 24 or 30 months of chemotherapy
compare marrow suppression in the two arms of maintenance treatment
次要结局
- overall and event-free survival(3 years after stop treatment)
- Hospitalization rate during maintenance treatment(24 or 30 months after chemotherapy)
研究者
Chi Kong Li
Dr.
Prince of Wales Hospital, Shatin, Hong Kong