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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00439920

Collaborator

(none)

Arm

266

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: High-dose anthracycline	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 1, 1996

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-dose anthracycline	Drug: High-dose anthracycline

Arm

Intervention/Treatment

Experimental: High-dose anthracycline

Drug: High-dose anthracycline

Outcome Measures

Primary Outcome Measures

Number of patients with complete response []
Patients are followed-up for response till death

Secondary Outcome Measures

Number of patients that reach disease-free-survival []
Patients are followed-up for response till death

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator: Franco Mandelli, Prof., Università degli Studi di Roma "La Sapienza"

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT00439920

Other Study ID Numbers:

LAL0496

First Posted:

Feb 26, 2007

Last Update Posted:

Oct 23, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

ALL

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Study Results

No Results Posted as of Oct 23, 2018