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

Purpose

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.

Condition	Intervention	Phase
Leukemia, Nonlymphocytic, Acute	Drug: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone Procedure: early allogeneic PBSCT within induction therapy Procedure: autologous PBSCT	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

overall survival
relapse-free survival

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	December 2003
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180102

Locations

Germany
Medical Department I, University Hospital Carl Gustav Carus
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Gerhard Ehninger, MD

University Hospital Carl Gustav Carus Dresden

More Information

No publications provided by Dresden University of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Büchner T, Schlenk RF, Schaich M, Döhner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Späth D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Döhner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the german AML intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.

Pfirrmann M, Ehninger G, Thiede C, Bornhäuser M, Kramer M, Röllig C, Hasford J, Schaich M; Study Alliance Leukaemia (SAL). Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial. Lancet Oncol. 2012 Feb;13(2):207-14. Epub 2011 Dec 22.

Responsible Party:	Prof. Dr. G. Ehninger, Medical Department I, University Hospital Dresden
ClinicalTrials.gov Identifier:	NCT00180102 History of Changes
Other Study ID Numbers:	MK1-95
Study First Received:	September 12, 2005
Last Updated:	December 23, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

acute myeloid leukemia
risk adapted treatment
early allogeneic stem cell transplantation
autologous stem cell transplantation

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Amsacrine
Cytarabine
Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013