AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years

Study Overview
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Brief Summary
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AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.

Detailed Description
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AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of blasts after first induction) and the donor situation is of utmost importance. For this fast search diagnostic, which is accomplished in all enclosed patients, significant resources are provided, to take the load off the participating centers. Furthermore, the relevance of autologous transplantation and the benefit of additional substances within the postremission therapy such as m-AMSA or mitoxantrone will be investigated. There is an up-front randomisation in four therapy arms with two cross-classifying factors of two stages (intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the intergroup treatment schedule of the German Competence Network is integrated into the AML2003 study as a central element and 25% of the patients are treated accordingly. In the intensified therapy arms a risk-adapted and priority-based therapy is implemented, including early allogeneic and consolidating autologous stem cell transplantation, respectively. In addition to the clinical questions , a detailed concomitant research program was initiated for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways for custom-made therapies.

Official Title
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AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.

Conditions
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Leukemia, Nonlymphocytic, Acute

Intervention / Treatment
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* Drug: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone
* Procedure: early allogeneic PBSCT within induction therapy
* Procedure: autologous PBSCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7 de novo or secondary myelodysplastic syndrome WHO-type RAEB-2 age 16 to 60 years written informed consent Exclusion Criteria: severe comorbidities severe, uncontrolled complications of the leukemia prior therapy for AML/MDS other simultaneous hematological malignancies HIV-Infection known allergies against study medication pregnancy missing written informed consent

Ages Eligible for Study
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Minimum Age: 16 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone|nan|
|Procedure: early allogeneic PBSCT within induction therapy|nan|
|Procedure: autologous PBSCT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| relapse-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate after induction therapy |  |  | 
| subgroup-analyses within the primary outcomes according to different risk factors |  |  | 
| development of explanatory proportional hazard-models |  |  | 

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