The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00199147
Recruitment Status : Unknown
Verified September 2005 by Johann Wolfgang Goethe University Hospital. Recruitment status was: Recruiting
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.
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
Study Start Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
61 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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%)