Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 49
- 主要终点
- Treatment feasibility
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
- To determine the complete response rate at the end of induction therapy in these patients.
- To determine the overall survival of patients treated with these regimens.
- To determine the disease-free survival of patients treated with these regimens.
- To determine the event-free survival of patients treated with these regimens.
- To determine toxicity of these regimens.
- To determine compliance related to dose intensity.
OUTLINE:
-
Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
-
Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
-
Consolidation therapy: Patients receive consolidation therapy according to risk group.
-
Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
-
High-risk patients: Patients receive consolidation therapy in 3 steps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（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
结局指标
主要结局
Treatment feasibility
时间窗: At 24 months from study entry.
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
次要结局
- Disease free survival(At three years from study entry)
- Safety(At 3 years from study entry)
- Event free survival(At 3 years from study entry)
- Overal survival(At 3 years from study entry)
- Compliance(At 3 years from study entry)