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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase: Unknown; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: High-dose anthracycline

Study type: Interventional

Funder types: Other

Identifiers

NCT00439920

LAL0496

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 16-60
• Diagnosed with previously untreated T-ALL and B-ALL

Exclusion criteria

• previously treated ALL patients
• L3 B-ALL

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

High-dose anthracycline

Experimental group

Treatment:

Drug: High-dose anthracycline