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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439920
First Posted: February 26, 2007
Last Update Posted: February 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
  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
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00439920     History of Changes
Other Study ID Numbers: LAL0496
First Submitted: February 23, 2007
First Posted: February 26, 2007
Last Update Posted: February 26, 2007
Last Verified: September 2000

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
ALL

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases