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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014