GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Fludarabine, AML, elderly patients
Eligibility Criteria
Inclusion Criteria:
- patients aged 60 to 75 years old
- untreated de novo AML
- performance status less than 2
Exclusion Criteria:
- performance status more than 2
- congestive heart failure or abnormal left ventricular ejection fraction
- severe hepatic or renal disturbances
- history of documented myelodysplastic or myeloproliferative syndrome
- patients previously treated with chemotherapy or radiation
Sites / Locations
- GOELAMS
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
Control arm without fludarabine Induction course: Ara-C 100mg/m2 days 1-7, idarubicin 8mg/m2 days 1-5, GM-CSF (molgramostim, Novartis) 5 microg/kg days 1 to neutrophil recovery; Consolidation course: Ara-C 1g/m2 q12h days 1-3, idarubicin 10mg/m2 days 2-3; and 3 quarterly reinduction courses during maintenance including Ara-C 80mg/m2 days 1-5, CCNU 40mg and mitoguazone 350mg/m2 day 1, ± fludarabine days 1-2.
Fludarabine arm The same regimen with fludarabine 20 mg/m2/day IV for 30 minutes induction course + fludarabine days 2-7; consolidation course + fludarabine days 4-5; during reinduction courses + fludarabine days 1-2.