Adult ALL Treatment at Diagnosis (LAL2000)

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00537550
First received: September 27, 2007
Last updated: September 28, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention
Leukemia, Lymphocytic, Acute
Drug: Vincristine
Drug: Vincristin, Daunorubicine, Asparaginase, Methotrexate

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Study Start Date: July 2000
Study Completion Date: June 2006
Intervention Details:
    Drug: Vincristine
    Steroids pre-treatment
    Drug: Vincristin, Daunorubicine, Asparaginase, Methotrexate
    Induction therapy
  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00537550

Locations
Italy
Az. Ospedaliera S. G. Moscati
Avellino, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
Ospedale Reg. A di Summa
Brindisi, Italy
Istituto di Ematologia- Ospedale San Carlo
Potenza, Italy
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"
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00537550     History of Changes
Other Study ID Numbers: LAL2000
Study First Received: September 27, 2007
Last Updated: September 28, 2007
Health Authority: Italy: The Italian Medicines Agency

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

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
Asparaginase
Methotrexate
Vincristine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on July 23, 2014