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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00439920
• Other study ID #: LAL0496
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1996
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients aged 16-60

• Diagnosed with previously untreated T-ALL and B-ALL

Exclusion Criteria:

• previously treated ALL patients

• L3 B-ALL

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• High-dose anthracycline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete response	Patients are followed-up for response till death
Secondary	Number of patients that reach disease-free-survival	Patients are followed-up for response till death