Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of complete remission
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
详细描述
Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
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
- 15 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated BCR-ABL-positive ALL
- •Age between 15 and 64 years
- •Performance status between 0 and 3 (ECOG criteria)
- •Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)
- •Written informed consent to participate in the trial
排除标准
- •Uncontrolled active infection
- •Another severe and/or life-threatening disease
- •Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
- •Another primary malignancy which is clinically active and/or requires medical interventions
- •Pregnant and/or lactating women
- •Past history of renal failure
研究组 & 干预措施
A
干预措施: imatinib (Drug)
A
干预措施: cyclophosphamide (Drug)
A
干预措施: daunorubicin (Drug)
A
干预措施: vincristine (Drug)
A
干预措施: prednisolone (Drug)
A
干预措施: methotrexate (Drug)
A
干预措施: cytarabine (Drug)
A
干预措施: dexamethasone (Drug)
结局指标
主要结局
The rate of complete remission
时间窗: 63 days
次要结局
- Overall survival(1 year)
- Toxicity caused by combination of imatinib and chemotherapy(2 years)
- The duration of remission(1 year)