Adult ALL Treatment at Diagnosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00537550
• Date of registration: 27/09/2007
• Primary sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Public title: Adult ALL Treatment at Diagnosis LAL2000
• Scientific title: GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
• Date of first enrolment: July 2000
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00537550
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Franco MANDELLI, Pr
• Affiliation: Università degli Studi di Roma "La Sapienza"

Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia, Lymphocytic, Acute

Intervention(s)

Drug: Vincristin, Daunorubicine, Asparaginase, Methotrexate

Drug: Vincristine

Secondary ID(s)

LAL2000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors