NCT00667927已完成1 期
Autologous Bone Marrow Transplant for Children With AML in First Complete Remission: Use of Marker Genes to Investigate the Biology of Marrow Reconstitution and the Mechanism of Relapse
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To estimate the continuous complete remission rate at 2 years for children with AML in first complete remission treated with Autologous Bone Marrow Transplant (ABMT).
研究概览
简要总结
This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).
详细描述
The primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with AML in first complete remission treated with autologous BMT.
Secondary objectives used transduction of marker genes into autologous marrow to determine the following:
- whether the source of relapse after BMT for AML is residual malignant cells in the harvested marrow or in the patient, and whether marrow purging is therefore rational.
- whether the majority of AML, which lack genetic markers, represent abnormalities in a multi-lineage progenitor cell, and whether therefore, auto grafting/intensified chemotherapy is ever likely to augment the cure rate.
- the mechanisms of autologous reconstitution, and the effects of stimuli which modify the process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol.
- •Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.
排除标准
- •Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant.
- •Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia)
- •Life expectancy limited by disease other than leukemia
- •Significant cardiac disease (echo shortening fraction <25% or MUGA scan <50%)
- •Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min
- •Severe restrictive pulmonary disease (FCV less than 40% of predicted)
- •Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU)
- •Severe personality disorder or mental illness
- •Previous severe cystitis from cyclophosphamide
- •Previous total dose of anthracyclines of >450 mg/m2
- •Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation
- •Previous autologous transplant
- •HIV reactivity
- •Karnofsky score <70%
研究组 & 干预措施
1
Other
干预措施: Busulfan (Drug)
1
Other
干预措施: Cyclophosphamide (Drug)
1
Other
干预措施: Mesna (Drug)
结局指标
主要结局
To estimate the continuous complete remission rate at 2 years for children with AML in first complete remission treated with Autologous Bone Marrow Transplant (ABMT).
时间窗: 2 years post transplant
次要结局
未报告次要终点
研究者
研究点 (1)
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