Spots Global Cancer Trial Database for Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
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Trial Identification
Brief Title: Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
Official Title: A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase
Study ID: NCT00514488
Conditions
Interventions
Study Description
Brief Summary: This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli", Bologna, , Italy
Contact Details
Name: Michele Baccarani, MD
Affiliation: Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
Role: PRINCIPAL_INVESTIGATOR
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