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

This study has been completed.

First Received on February 23, 2007. No Changes Posted

Sponsor:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:	NCT00439920

Purpose

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

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: High-dose anthracycline	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Study Start Date:	October 1996
Estimated Study Completion Date:	May 2006

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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439920

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator:

Franco Mandelli, Prof.

Università degli Studi di Roma "La Sapienza"

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00439920 History of Changes
Other Study ID Numbers:	LAL0496
Study First Received:	February 23, 2007
Last Updated:	February 23, 2007
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

ALL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012