Status:
UNKNOWN
Efficacy of G-CSF-Priming in Elderly AML Patients
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
61+ years
Phase:
PHASE4
Brief Summary
Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00199147
Start Date
January 1 2000
Last Update
October 26 2005
Active Locations (1)
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1
University Hospital, Medical Department II
Frankfurt, Germany, 60590