Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

Study Overview
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Brief Summary
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Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

Detailed Description
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Measuring EFS depending on induction therapy

Official Title
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Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.

Conditions
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Acute Myeloid Leukaemia

Intervention / Treatment
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* Drug: Cytarabine
* Biological: human stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification written informed consent Exclusion Criteria: pretreatment of leukemia no informed consent simultaneous inclusion in other studies mental disability contraindication for intensive chemotherapy AML FAB M3 contraindication for allogeneic stem cell transplantation restriction of following organ functions: creatinine-clearance < 50 ml/min cardiac ejection fraction < 40 % severe pulmonary restriction bilirubin > 2x ULN; SGOT and SGPT > 4x ULN uncontrolled hypertension severe uncontrolled metabolism disturbance Karnofsky-performance-score < 70% hepatitis C other malignancy age of unrelated donor >70 years and age of related donor >75 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard arm<br>standard treatment arm | Drug: Cytarabine<br>* Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.<br>* Other names: AraC;|
| Experimental: OSHO - intensified consolidation<br>Intermediate dose AraC | Drug: Cytarabine<br>* Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.<br>* Other names: AraC;|
| Experimental: OSHO - allografting as consolidation<br>allogeneic stem cell Transplantation versus no transplantation | Biological: human stem cells<br>* Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival | comparison of event free survival (OSHO arm versus Standard intergroup arm) | after 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | at 5 years | 
| LFS | leukemia free survival | at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML