GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.

Gruppo Italiano Malattie EMatologiche dell'Adulto

Overview

The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Lymphoblastic Leukemia

Interventions

High-dose anthracyclineDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 16-60 * Diagnosed with previously untreated T-ALL and B-ALL Exclusion Criteria: * previously treated ALL patients * L3 B-ALL

Outcomes

Primary Outcomes

Number of patients with complete response

Patients are followed-up for response till death

Secondary Outcomes

Number of patients that reach disease-free-survival

Patients are followed-up for response till death

Data from ClinicalTrials.gov

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