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NCT Number: NCT00180102

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

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.

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Key information

Conditions

Leukemia, Nonlymphocytic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Department I, University Hospital Carl Gustav Carus

Dresden, 01307, Germany

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone

Drug

early allogeneic PBSCT within induction therapy

Procedure

autologous PBSCT

Procedure

Primary outcomes

  1. overall survival

  2. relapse-free survival

Secondary outcomes

  1. complete remission rate after induction therapy

  2. subgroup-analyses within the primary outcomes according to different risk factors

  3. development of explanatory proportional hazard-models

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Dec 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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