AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

Study Overview
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Brief Summary
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The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

Detailed Description
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The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

Official Title
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AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.

Conditions
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Leukemia, Nonlymphoblastic, Acute

Intervention / Treatment
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* Drug: Cytarabine Dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7 de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T written informed consent Exclusion Criteria: severe comorbidities severe uncontrolled complications of the leukemia previous therapy of leukemia/MDS HIV-Infection known relevant allergy against study medication pregnancy missing written informed consent

Ages Eligible for Study
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Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: Cytarabine Dosage|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - rate of complete remission |  |  | 
| - overall survival |  |  | 
| - relapse-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - frequencies and grade of treatment side effects |  |  | 
| - deaths within induction therapy |  |  | 
| - deaths within postremission therapy |  |  | 
| - feasibility according to dosages and time-intervals |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation