Adult ALL Treatment at Diagnosis (LAL2000)

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. Identifier: NCT00537550
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : October 1, 2007
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto

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
Leukemia, Lymphocytic, Acute Drug: Vincristine Drug: Vincristin, Daunorubicine, Asparaginase, Methotrexate Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : July 2000
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Vincristine
    Steroids pre-treatment
    Drug: Vincristin, Daunorubicine, Asparaginase, Methotrexate
    Induction therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
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

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 identifier (NCT number): NCT00537550

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
Principal Investigator: Franco MANDELLI, Pr Università degli Studi di Roma "La Sapienza" Identifier: NCT00537550     History of Changes
Other Study ID Numbers: LAL2000
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: September 2007

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators