EUCTR2009-016075-30-ITActive, not recruitingPhase 1
Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000 - GIMEMA LAL 1308
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO0 sites30 target enrollmentStarted: July 20, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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