Status:
COMPLETED
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years
Lead Sponsor:
Technische Universität Dresden
Conditions:
Leukemia, Nonlymphocytic, Acute
Eligibility:
All Genders
16-60 years
Phase:
PHASE4
Brief 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.
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00180102
Start Date
December 1 2003
End Date
November 1 2009
Last Update
December 24 2009
Active Locations (1)
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1
Medical Department I, University Hospital Carl Gustav Carus
Dresden, Germany, 01307