Trial Information

AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10

GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with
DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed
by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same
anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55
yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted
with autologous peripheral stem cell (PSC) collected during recovery from consolidation.

BM and PB samples at diagnosis were centralized according to a national GIMEMA original
study planned with the aim to accurately evaluate biological characteristics at diagnosis
and to identify genetic alterations with prognostic relevance and to follow up cases
monitoring minimal disease during remission. To allow the adequate collection and sending of
samples before starting intensive chemotherapy, all patients received a 5-day pretreatment
consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for “debulkying”
of disease.