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

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00439920
First received: February 23, 2007
Last updated: NA
Last verified: September 2000
History: No changes posted
  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 2

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:


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 April 17, 2014