AML Treatment in Untreated Adult Patients (LAM99P)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Unknown

Conditions: Leukemia, Myelocytic, Acute

Treatments: Procedure: Transplant; Procedure: Identification of appropriate therapies according to risks factors; Drug: Daunorubicine

Study type: Interventional

Funder types: Other

Identifiers

NCT00449319

LAM99P

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 15 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AML "de novo" with bone marrow blasts <=30%
• Performance status: 0-3
• FAB subtype: all except M3
• Written informed consent

Exclusion criteria

• age <15 years and >= 61 years
• pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
• diagnosis of acute promyelocitic leukemia (M3)
• Performance status = 4
• Uncontrolled infection

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)