Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Treatment Active 16 to 60 Other MK1-95 NCT00180102

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Technische Universitaet Dresden

Gerhard Ehninger, MD

Principal Investigator

Markus Schaich, MD		Ph: +49-351-458 Ext.-4251
		Email: markus.schaich@uniklinikum-dresden.de

Silke Soucek		Ph: +49-351-458 Ext.-4251
		Email: silke.soucek@uniklinikum-dresden.de

Germany
	Dresden
	Universitatsklinikum Carl Gustav Carus
		Markus Schaich, MD	Ph: +49-351-458 Ext.-4251
			Email: markus.schaich@uniklinikum-dresden.de
		Silke Soucek	Ph: +49-351-458 Ext.-4251
			Email: silke.soucek@uniklinikum-dresden.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00180102
Information obtained from ClinicalTrials.gov on May 29, 2008