ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,559
- 试验地点
- 75
- 主要终点
- Efficacy of dexamethasone vs prednisone during the induction phase
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 young patients with acute lymphoblastic leukemia.
PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Compare the relative efficacy of induction therapy comprising dexamethasone or prednisone, in terms of a higher rate of event-free survival (EFS) and overall survival and a reduced rate of relapse, in pediatric patients with intermediate-risk or high-risk acute lymphoblastic leukemia (ALL).
- Compare the relative safety of a reduced-intensity reintensification regimen comprising dexamethasone, vincristine, cyclophosphamide, and anthracyclines vs a standard treatment regimen in pediatric patients with standard-risk ALL identified by fast clearance of leukemic cells.
- Compare the efficacy of a second delayed reintensification regimen vs standard reintensification therapy, in terms of improved EFS, in pediatric patients with intermediate-risk ALL.
- Compare the efficacy of extended reintensification therapy (triple reinduction) vs standard reintensification therapy (intensive pulses and one reintensification) in pediatric patients with high-risk ALL.
OUTLINE: This is a randomized, multicenter study.
-
Prednisone prephase therapy: Patients receive oral prednisone on days 1-7 and one dose of methotrexate (MTX) intrathecally (IT) on day 1.
-
Induction/consolidation therapy, protocol I: Patients are randomized to 1 of 2 treatment arms.
-
Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28.
-
Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 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
Induction Prot I/Dexa - reinduction Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Dexa - reinduction Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: prednisone (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Pred - reinduction Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: vindesine (Drug)
Induction Prot I/Pred - reinduction Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Dexa - reinduction Prot II
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: cytarabine (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: ifosfamide (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: mercaptopurine (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: methotrexate (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: prednisone (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: thioguanine (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: vincristine sulfate (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction Prot II
干预措施: radiation therapy (Radiation)
Induction Prot I/Pred - reinduction Prot II
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: cyclophosphamide (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: dexamethasone (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: methotrexate (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: thioguanine (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: vincristine sulfate (Drug)
Induction Prot I/Pred - reinduction Prot II
干预措施: radiation therapy (Radiation)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Dexa - reinduction 2x Prot III
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: vindesine (Drug)
Induction Prot I/Pred - reinduction 2x Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: etoposide (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: prednisone (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: cyclophosphamide (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: dexamethasone (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: etoposide (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: methotrexate (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: thioguanine (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: vincristine sulfate (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: vindesine (Drug)
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
干预措施: radiation therapy (Radiation)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: cyclophosphamide (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: cytarabine (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: dexamethasone (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: etoposide (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: ifosfamide (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: mercaptopurine (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: methotrexate (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: prednisone (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: thioguanine (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: vincristine sulfate (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: vindesine (Drug)
Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
干预措施: radiation therapy (Radiation)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: asparaginase (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: cyclophosphamide (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: cytarabine (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: daunorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: dexamethasone (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: doxorubicin hydrochloride (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: etoposide (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: ifosfamide (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: mercaptopurine (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: methotrexate (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: prednisone (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: thioguanine (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: vincristine sulfate (Drug)
Induction Prot I/Pred - reinduction 6 HR courses + Prot II
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Efficacy of dexamethasone vs prednisone during the induction phase
时间窗: End of Trial
Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients
时间窗: End of Trial
Safety and efficacy of treatment reduction during reintensification in standard-risk patients
时间窗: End of Trial
EFS after second delayed reintensification in intermediate-risk patients
时间窗: End of Trial
Outcome after extended reintensification therapy in high-risk patients
时间窗: End of Trial
次要结局
未报告次要终点
研究者
Martin Schrappe
Prof. Dr. med.
University Hospital Schleswig-Holstein