Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient more than 18 year old
- •De novo or secondary leukemia.
- •Treated with FLAG regimen
排除标准
- •Acute promyelocytic leukemia (APL)
结局指标
主要结局
Overall survival
时间窗: 3 years
For evaluating the FLAG effect, OS was defined from consolidation randomization to death from any cause (censored at last contact).
次要结局
- Relapse-free survival(2 years)
- Severe adverse events(45 days)
- Complete Remission Rate(2 months)
- Event-Free Survival Rate(2 years)
研究者
ZhongHong Shao
head of department of Hematology
Tianjin Medical University General Hospital