Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Acute Myeloblastic Leukaemia

Intervention / Treatment
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* Drug: ARA-C
* Drug: Idarubicin
* Drug: Leucomax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARA-C|nan|
|Drug: Idarubicin|nan|
|Drug: Leucomax|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the toxicity |  |  | 
| Evaluate the effect of haematopoietic growth factors |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloblastic Leukaemia