LAL2000: Adult ALL Treatment at Diagnosis

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Completed
CT.gov ID
NCT00537550
Collaborator
(none)
5
71

Study Details

Study Description

Brief Summary

The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
Study Start Date :
Jul 1, 2000
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of acute lymphoblastic leukemia (ALL)

    • Negative myeloperoxidase stain

    • Phenotype T (ALL-T) and B(ALL-B)

    Exclusion Criteria:
    • Creatinine > 2.5mg/dL after adequate hydratation

    • LVEF <50%

    • Presence of documented infections not responding to antibiotic and/or antifungal therapy

    • Presence of concomitant malignant diseases

    • Absence of any psychological condition that does not allow to intake high doses of cortisone

    • Patients who have received any antineoplastic chemiotherapy for more than 5 days

    • Patients who have received any steroids for more than 10 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Az. Ospedaliera S. G. Moscati Avellino Italy
    2 Ist.Ematologia e Oncologia Medica L.e A. Seragnoli Bologna Italy
    3 Ospedale Reg. A di Summa Brindisi Italy
    4 Istituto di Ematologia- Ospedale San Carlo Potenza Italy
    5 Policlinico G.B. Rossi Verona Italy 37134

    Sponsors and Collaborators

    • Gruppo Italiano Malattie EMatologiche dell'Adulto

    Investigators

    • Principal Investigator: Franco MANDELLI, Pr, Università degli Studi di Roma "La Sapienza"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00537550
    Other Study ID Numbers:
    • LAL2000
    First Posted:
    Oct 1, 2007
    Last Update Posted:
    Oct 1, 2007
    Last Verified:
    Sep 1, 2007

    Study Results

    No Results Posted as of Oct 1, 2007