AML Treatment in Untreated Adult Patients (LAM99P)
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.
Leukemia, Myelocytic, Acute
Procedure: Identification of appropriate therapies according to risks factors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Official Title:||AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10|
|Study Start Date:||November 1998|
|Study Completion Date:||December 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449319
|Dr. De Blasio|
|Nocera Inferiore, Italy|
|Reggio Calabria, Italy|
|Pr. Lo Coco|
|San Giovanni Rotondo, Italy|
|Principal Investigator:||Franco MANDELLI, Pr.||Gruppo Italiano Malattie EMatologiche dell'Adulto|