A phase III trial in adult acute myelogenous leukemia AML comparing 1 standard-dose versus high-dose remission induction therapy and 2 , within a risk-oriented postremission strategy, an autologous blood stem cell transplantation versus an autologous blood stem cell-supported multicycle high-dose program Protocol NILG-AML 02/06 .

INTERVENTION: Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Etoposide CAS Number: 33419‐42‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Cytarabine CAS Number: 147‐94‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Idarubicin CAS Number: 57852‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 18‐ Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Cytarabine CAS Number: 147‐94‐4 Concentration unit: g gram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Idarubicin CAS Number: 57852‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12‐ Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Busulfan CAS Number: 57852‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .8‐ Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Cyclophosphamide CAS Number: 57852‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Mesna CAS Number: 57852‐57‐0 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.5‐ CONDITION: PATIENT WHIT LMA ; MedDRA version: 8.1 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid PRIMARY OUTCOME: Main Objective: Remission induction R1 Primary endpoint Complete remission CR rate after cycle 1 Remission consolidation R2 Primary endpoint Length of remission DFS, disease‐free survival Primary end point(s): FOR R1 Remission induction R1 Primary endpoint FOR R2 Primary endpoint Length of remission DFS, disease‐free survival Secondary Objective: Remission induction R1 Secondary efficacy outcome measures 1. CR with incomplete hematology recovery CRi 2. Complete cytogenetic remission CRc 3. Treatment‐related death TRD 4. Feasibility and efficacy of treatments in different age and risk groups Safety outcome measures Toxicity clinical adverse events Remission consolidation R2 Secondary efficacy outcome measures 1. Overall survival OS 2. Remission duration and cumulative incidence of relapse CIR 3. Treatment‐related death TRD 4. Feasibility and efficacy of treatments in different age and risk groups 5. Significance and clinical correlates of remission monitoring results 6. Quality of Life evaluation in long term survivors Safety outcome measures Toxicity clinical adverse events Outcome study Descriptive analyses of the patients not included in R1 and R2. Prospective analysis of risk‐oriented allogeneic stem cell transplantation strategies. For patients in Random 1, explorative ana INCLUSION CRITERIA: FOR R1 1. A diagnosis of untreated AML or high‐risk MDS is required. 2. The diagnosis must be one of o de novo AML and variants thereof including rare diagnostic subsets , o secondary AML, o MDS‐related AML or high‐risk MDS RAEB‐2 by WHO criteria , o primary myeloid sarcoma MS 3. Age 16 years. 4. ECOG performance status 0‐2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures. 5. Informed consent signed by the patient or by a parent/tutor in patients aged 18 years. FOR R2 1. Confirmed CR status after Random 1 check of BM and PB morphology 2. Sufficient amount of autologous blood stem cells 2 x106/kg following A8 consolidation/mobilization chemotherapy cycle no. 3 3. Age 65 years 4. Signed informed consent by the patient or by parent/tuto