Efficacy of G-CSF-Priming in Elderly AML Patients
Phase 4
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT00199147
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- 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 IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method -Remission rate after induction therapy -Remission duration -Disease free survival -Overall survival
- Secondary Outcome Measures
Name Time Method -Toxicity according to WHO -Death in induction therapy -Feasibility to mobilize peripheral blood stem cells -Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients
Trial Locations
- Locations (1)
University Hospital, Medical Department II
🇩🇪Frankfurt, Germany