Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

PETHEMA Foundation

Status and phase: Completed; Phase 4

Conditions: Acute Myeloblastic Leukaemia

Treatments: Drug: Leucomax; Drug: Idarubicin; Drug: ARA-C

Study type: Interventional

Funder types: Other

Identifiers

NCT00464217

PETHEMA/LAM-99

Details and patient eligibility

About

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

Full 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)

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)