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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
  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:


Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden
  More Information

No publications provided by Technische Universität Dresden

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

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 Technische Universität Dresden:
acute myeloid leukemia
risk adapted treatment
early allogeneic stem cell transplantation
autologous stem cell transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Mitoxantrone
Analgesics
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014