Adult ALL Treatment at Diagnosis - Full Text View

Adult ALL Treatment at Diagnosis (LAL2000)

This study has been completed.

First Received: September 27, 2007 Last Updated: September 28, 2007 History of Changes

Sponsored by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:	NCT00537550

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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Vincristine Methotrexate Vincristine sulfate L-Asparaginase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis

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

Study Start Date:	July 2000
Study Completion Date:	June 2006

Intervention Details:

Steroids pre-treatment

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537550

Locations

Italy
Az. Ospedaliera S. G. Moscati
Avellino, Italy
Policlinico G.B. Rossi
Verona, Italy, 37134
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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

ALL
Adult

Study placed in the following topic categories:

Antimetabolites
Asparaginase
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
Vincristine
Antimitotic Agents
Folic Acid Antagonists
Immunosuppressive Agents

Folic Acid
Leukemia
Lymphatic Diseases
Tubulin Modulators
Methotrexate
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase

Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators

ClinicalTrials.gov processed this record on May 06, 2009