Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000 - GIMEMA LAL 1308

Phase 1

Conditions: Acute Lymphoblastic Leukemia (ALL)
MedDRA version: 9.1Level: LLTClassification code 10000844

Registration Number: EUCTR2009-016075-30-IT

Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

ALL not-B mature, not Ph+ patients, phenotype line T (LLA-T) or B (LLA-B), aged =18 and <35 years (until 34 years and 364 days) and who have signed an informed consent in compliance with ICH-GCP and the applicable national laws.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age < 18 and =35 years - Patients who have performed a steroid pretreatment before being registered in the study - Patients who performed an antiblastic chemotherapic pretreatment - Patients with ALL-B mature (FAB L3, sIg+, TdT-) - Patinets with Biphenotypic Acute Leukemia (EGIL criteria) - Patients with t(9;22) ALL - Patients with a punctio sicca and peripherical blasts absence - Patients with Acute undifferentiated Leukemia - Patients with serum creatinine > 2.5 mg / dl after adequate hydration - Patients with transaminases > 3 times the maximum normal value - Patients with left ventricular ejection fraction (FEV) <50% - Patients with a severe mental illness - Presence of concomitant malignant diseases - Presence of documented infections not responding to antibiotic and / or antifungal therapy - Pregnant women or lactating - Down Syndrome.