Trial Information

A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

Eligibility for enrollment in the study was limited to patients aged 60 to 75 years old with
previously untreated de novo AML as defined morphologically by the French-American-British
(FAB) classification with the exception of M3 and M7 subtypes.10,11 The bone marrow aspirate
had to show at least 30 percent of nonerythroid blast cells. Patients were not eligible if
they had a performance status before diagnosis of 2 or more according to the World Health
Organization (WHO) grading system, congestive heart failure or abnormal left ventricular
ejection fraction, severe hepatic or renal disturbances if not related to leukemia (hepatic
enzymes levels over four times the normal values, serum bilirubin over 35 micromol/L,
creatinine over 150 micromol/L). Patients with previous unexplained cytopenia were eligible
for the study. Conversely, patients with a history of documented myelodysplastic or
myeloproliferative syndrome or previously treated with chemotherapy or radiation could not
enter the study. The study received in June 1996 approval from the ethics' board of the
Nancy Hospital and written informed consent was given by all eligible patients before
entering the study, in accordance with the Declaration of Helsinki. The enrollment period
was open from November 1996 to April 2000.