Adult ALL Treatment at Diagnosis (LAL2000)

September 28, 2007 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy
        • Az. Ospedaliera S. G. Moscati
      • Bologna, Italy
        • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
      • Brindisi, Italy
        • Ospedale Reg. A di Summa
      • Potenza, Italy
        • Istituto di Ematologia- Ospedale San Carlo
      • Verona, Italy, 37134
        • Policlinico G.B. Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 1, 2007

Last Update Submitted That Met QC Criteria

September 28, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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