PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
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)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Garcia Laraña Jose, Dr
Principal Investigator
Hospital Ramón y Cajal
Spain: Ministry of Health
PETHEMA/LAM-99
NCT00464217
October 1998
December 2008
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