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

Phase 4

Completed

• Conditions: Leukemia, Nonlymphocytic, Acute

• Registration Number: NCT00180102
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
relapse-free survival
overall survival

Secondary Outcome Measures

Name	Time	Method
complete remission rate after induction therapy
subgroup-analyses within the primary outcomes according to different risk factors
development of explanatory proportional hazard-models

Trial Locations

Locations (1)

Medical Department I, University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Germany