Induction Intensification in Infant ALL: A Children's Oncology Group Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 140
- 主要终点
- Feasibility of intensification
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.
PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Assess the feasibility of intensification with two courses of high-dose methotrexate followed by one course of cyclophosphamide/etoposide during induction and later as consolidation in infants with newly diagnosed acute lymphoblastic leukemia.
- Determine event-free survival after shortened, intensive therapy in these patients.
- Compare event-free survival rates of infants receiving this regimen whose leukemic blasts have or do not have translocations involving the 11q23 gene MLL.
Secondary
- Correlate the presence of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome.
- Investigate the clinical prognostic features that may be associated with outcome in infants, such as bone marrow blast content at day 8, white blood cell count, and age.
- Correlate biologic characteristics of the leukemia cells at diagnosis (protocol POG-9900) with outcome in patients treated with this regimen.
- Characterize patterns of gene expression associated with host and disease characteristics and treatment response in patients treated with this regimen.
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
- — 至 1 Year（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
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: leucovorin calcium (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: asparaginase (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: cyclophosphamide (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: filgrastim (Biological)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: cytarabine (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: daunorubicin hydrochloride (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: etoposide (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: mercaptopurine (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: methotrexate (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: prednisone (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: therapeutic hydrocortisone (Drug)
Chemo (Reduced Induction) No BMT (Open February 2004)
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Feasibility of intensification
Event-free survival
Comparison of event-free survival rates in infants with and without leukemic blasts translocations
次要结局
- Correlation of biologic characteristics of leukemia cells at diagnosis with outcome
- Patterns of gene expression
- Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome
- Clinical prognostic features associated with outcome