Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation
Inclusion Criteria:
- Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or
- Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or
after preceeding MDS or
- Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or
- Extramedullary AML (chloroma, “granulocytic sarcoma”)
- Age greater than 60 years (not including 60 years)
- ECOG performance status 0, 1, or 2
- Written informed consent
Exclusion Criteria:
- Patients with a t(15;17) translocation
- Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial
infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
- Patients with severe complications of the leukemia such as uncontrolled bleeding,
pneumonia with hypoxia or shock.
- Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
- Significant renal dysfunction (creatinine clearance < 60/min/min)
- Bilirubin > 2mg% (>34.2 mmol/l)
- Patients with a clinically active second malignancy
- Patients with a psychiatric, addictive, or any disorder wich compromises ability to
give truly informed consent for participating in this study
- HIV positivity
- Known refractoriness to platelet transfusion, inability to adequately substitute
blood products