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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
High-dose anthracycline
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring ALL

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    High-dose anthracycline

    Arm Description

    Outcomes

    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

    Full Information

    First Posted
    February 23, 2007
    Last Updated
    October 22, 2018
    Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00439920
    Brief Title
    GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1996 (Actual)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Lymphoblastic Leukemia
    Keywords
    ALL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A

    8. Arms, Groups, and Interventions

    Arm Title
    High-dose anthracycline
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    High-dose anthracycline
    Primary Outcome Measure Information:
    Title
    Number of patients with complete response
    Description
    Patients are followed-up for response till death
    Secondary Outcome Measure Information:
    Title
    Number of patients that reach disease-free-survival
    Description
    Patients are followed-up for response till death

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franco Mandelli, Prof.
    Organizational Affiliation
    Università degli Studi di Roma "La Sapienza"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34048072
    Citation
    Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
    Results Reference
    derived

    Learn more about this trial

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

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