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Trial Title:
Efficacy of G-CSF-Priming in Elderly AML Patients
NCT ID:
NCT00199147
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Cytarabine
Fludarabine
Etoposide
Idarubicin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cytarabine
Intervention type:
Drug
Intervention name:
Etoposide
Intervention type:
Drug
Intervention name:
Idarubicin
Intervention type:
Drug
Intervention name:
G-CSF
Intervention type:
Drug
Intervention name:
Fludarabine
Intervention type:
Procedure
Intervention name:
Stem cell apheresis
Intervention type:
Procedure
Intervention name:
Stem cell transplantation
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
61 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital, Medical Department II
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Oliver G Ottmann, MD
Phone:
++49-69-6301-4802
Email:
ottmann@em.uni-frankfurt.de
Contact backup:
Last name:
Gesine Bug, MD
Phone:
++49-69-6301-4802
Email:
g.bug@em.uni-frankfurt.de
Investigator:
Last name:
Oliver G Ottmann, MD
Email:
Principal Investigator
Investigator:
Last name:
Gesine Bug, MD
Email:
Sub-Investigator
Start date:
January 2000
Lead sponsor:
Agency:
Johann Wolfgang Goethe University Hospital
Agency class:
Other
Source:
Johann Wolfgang Goethe University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00199147
