Spots Global Cancer Trial Database for Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Study Description

Brief Summary: 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

Detailed Description: 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)

Keywords

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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