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 enrollmentJuly 20, 2010

Overview

No summary available.

Registry

who.int

Start Date

July 20, 2010

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

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

•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

•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.