GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Drug: High-dose anthracycline
- Registration Number
- NCT00439920
- Brief Summary
The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.
- Detailed Description
The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.
This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients aged 16-60
- Diagnosed with previously untreated T-ALL and B-ALL
- previously treated ALL patients
- L3 B-ALL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-dose anthracycline High-dose anthracycline -
- Primary Outcome Measures
Name Time Method Number of patients with complete response Patients are followed-up for response till death
- Secondary Outcome Measures
Name Time Method Number of patients that reach disease-free-survival Patients are followed-up for response till death