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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180102
First received: September 12, 2005
Last updated: December 23, 2009
Last verified: December 2009

September 12, 2005
December 23, 2009
December 2003
November 2009   (final data collection date for primary outcome measure)
  • overall survival
  • relapse-free survival
  • - overall survival
  • - relapse-free survival
Complete list of historical versions of study NCT00180102 on ClinicalTrials.gov Archive Site
  • complete remission rate after induction therapy
  • subgroup-analyses within the primary outcomes according to different risk factors
  • development of explanatory proportional hazard-models
  • - complete remission rate after induction therapy
  • - subgroup-analyses within the primary outcomes according to different risk factors
  • - development of explanatory proportional hazard-models
Not Provided
Not Provided
 
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Nonlymphocytic, Acute
  • Drug: Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone
  • Procedure: early allogeneic PBSCT within induction therapy
  • Procedure: autologous PBSCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00180102
MK1-95
Not Provided
Prof. Dr. G. Ehninger, Medical Department I, University Hospital Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden
Technische Universität Dresden
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP