Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
详细描述
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.
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 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated BCR-ABL-negative ALL
- •Age between 15 and 24 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: Methotrexate (Drug)
A
干预措施: Prednisolone (Drug)
A
干预措施: Dexamethasone (Drug)
A
干预措施: Vincristine (Drug)
A
干预措施: Pirarubicin (Drug)
A
干预措施: Cyclophosphamide (Drug)
A
干预措施: L-asparaginase (Drug)
A
干预措施: Cytarabine (Drug)
A
干预措施: Hydrocortisone (Drug)
A
干预措施: Mercaptopurine (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- The rate of complete remission(3 years)