Leukemia, Myelocytic, Acute Clinical Trial
Official title:
AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
The present therapy intends to be an homogeneous treatment for AML patients based on a
pretreatment with hydroxiurea plus an induction therapy with the standard arm with
Daunorubicine as according to EORTC-GIMEMA AML10 study.
The post-remissional treatment is based on transplant with HLA compatible donor is foreseen
for all patients and autologous transplant for those without HLA compatible donor available.
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.
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