A Phase 3 interventional study of G-CSF in AML, sponsored by Turkish Leukemia Study Group. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-01-12.
Sponsored by Turkish Leukemia Study Group · Phase 3, Interventional, and Treatment
Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery following induction chemotherapy are widely accepted. However, their impact on response and survival has not been clarified yet. Male gender has been claimed to be a susceptibility factor for development of leukemia and shorten survival but effect of sex has not been analyzed in clinical trials utilizing G-CSF.
Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy was assessed in this prospective randomized Phase III multicenter trial. Patients were randomized to receive induction therapy consisting of either cytosine arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over 0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).
After achievement of CR, all patients received first consolidation course of Ara-C 1 gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor they were randomized to receive second course of consolidation either high dose Ara-C 3 gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.
This is the only study on the registry with Turkish Leukemia Study Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
remission induction with cytosine arabinoside amd idarubicine
G-CSF was administered starting on Day 8 until neutrophil recovery
Drug: G-CSF
Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery
Also known as: Neupogen
response to induction
Time frame: 3 year
overall survival
Time frame: 3 year
No study locations are listed for this record.
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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