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临床试验/NCT00464217
NCT00464217已完成4 期

PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

PETHEMA Foundation28 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1998年10月1日最近更新:
适应症
相关药物

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

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

研究者

发起方
PETHEMA Foundation
申办方类型
Other

研究点 (28)

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