A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy.
研究概览
简要总结
The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)
详细描述
The present protocol will compare the biologic effects of PEG-asparaginase vs native-forms of asparaginase in a randomized trial using the same dosages and schedules used in the POG 9411 study. Comprehensive studies, including the measurement of antibodies and asparagine levels as well as the pharmacokinetics of L-asparaginase, will be performed. This protocol will also study the changes in topoisomerase I and topoisomerase II levels and the fractions of topoisomerase I/II translocations in malignant lymphoblasts after upfront window topotecan therapy, and correlate oncolytic response with these changes.
Secondary objectives include:
- To compare changes in asparagine levels 28 days after initiation of treatment with asparaginase between the two groups.
- To estimate the pharmacokinetics of L-asparaginase, compare the pharmacokinetics between the two groups of patients, and correlate the pharmacokinetics with the development of antibody to asparaginase and depletion of asparagine.
- To measure the pharmacokinetics and pharmacodynamics of topotecan in patients with recurrent acute lymphoblastic leukemia
- To determine whether the frequency of recombinogenesis in lymphocytes is increased during or after etoposide therapy relative to the pre-therapy level, and to explore whether etoposide pharmacokinetics are related to the Day 7 or post-therapy level of recombinogenesis.
Detailed Description of Treatment Plan
WINDOW Topotecan 2.4 mg/m2 ; IV over 30 min in 5 doses Days 1-5
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 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
1
Native asparaginase
干预措施: Topotecan, dexamethasone, vincristine (Drug)
1
Native asparaginase
干预措施: E. coli Asparaginase, PEG-L-asparaginase (Drug)
1
Native asparaginase
干预措施: erwinia asparaginase (Drug)
1
Native asparaginase
干预措施: fludarabine, methotrexate, mercaptopurine (Drug)
1
Native asparaginase
干预措施: idarubicin, etoposide, cytarbine, teniposide (Drug)
1
Native asparaginase
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
2
PEG-asparaginase
干预措施: Topotecan, dexamethasone, vincristine (Drug)
2
PEG-asparaginase
干预措施: E. coli Asparaginase, PEG-L-asparaginase (Drug)
2
PEG-asparaginase
干预措施: erwinia asparaginase (Drug)
2
PEG-asparaginase
干预措施: fludarabine, methotrexate, mercaptopurine (Drug)
2
PEG-asparaginase
干预措施: idarubicin, etoposide, cytarbine, teniposide (Drug)
2
PEG-asparaginase
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
结局指标
主要结局
To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy.
时间窗: December 2003
次要结局
未报告次要终点