Status:
COMPLETED
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Lead Sponsor:
University of Ulm
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
16-60 years
Phase:
PHASE3
Brief Summary
The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups ...
Eligibility Criteria
Inclusion
- Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
- Cytogenetical tests must be performed for each patient
- Age: 16 - 60 years
- All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
Exclusion
- Organic insufficiency: Insufficiency of the kidneys (Crea \> 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP \> 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction \< 0.5
- Secondary malignom
- Other severe diseases
- Pregnancy
- Participation in an concurrent clinical study
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00146120
Start Date
May 1 1998
End Date
May 1 2005
Last Update
February 9 2009
Active Locations (22)
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1
Department of Hematology / Oncology, University Hospital of Innsbruck
Innsbruck, Austria, 6020
2
III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien
Vienna, Austria, 1140
3
Department of General Internal Medicine, University Hospital of Bonn
Bonn, Germany, 53127
4
Department of Internal Medicine Hematology, Heinrich-Heine University
Düsseldorf, Germany, 40225