PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
研究概览
简要总结
To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction
详细描述
INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (> 1.000/mm 3)
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol.
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (>1.000/mm 3)
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
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
- •Over 65 years
排除标准
- •Previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome
- •Previous treatment with antileucemic chemotherapy
- •Psychiatric disorder
- •Diagnosis of subtype FAB M3
- •Creatinine > 2.5 mg/dL
- •Bilirubin , Alkaline Phosphatase or transaminases three times upper the limit
结局指标
主要结局
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
次要结局
- Evaluate the toxicity
- Evaluate the effect of haematopoietic growth factors
