GIMEMA LAL 0496: High-Dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.
16 Years
60 Years
Both
Acute Lymphoblastic Leukemia
Trial Information
GIMEMA LAL 0496: High-Dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.
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.
Inclusion Criteria:
- Patients aged 16-60
- Diagnosed with previously untreated T-ALL and B-ALL
Exclusion Criteria:
- previously treated ALL patients
- L3 B-ALL
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Franco Mandelli, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Università degli Studi di Roma "La Sapienza"
Authority:
Italy: The Italian Medicines Agency
Study ID:
LAL0496
NCT ID:
NCT00439920
Start Date:
October 1996
Completion Date:
May 2006
Related Keywords:
- Acute Lymphoblastic Leukemia
- ALL
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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