Trial | NCT00464217  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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
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)
Study Started
Oct 31
1998
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Jan 05
2010
Estimate

Drug ARA-C

Drug Idarubicin

Drug Leucomax

Criteria 

Inclusion Criteria:

Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
Over 65 years

Exclusion Criteria:

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
No Results Posted