Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) (CML022)
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|ClinicalTrials.gov Identifier: NCT00514488|
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : August 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: STI571 (400 mg/day; or 800 mg/day)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2004|
- To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily.
- The rate of major cytogenetic response,the kinetic and duration of cytogenetic response, the time to accelerated and blast crisis and overall survival,safety and tolerability of the treatment.
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 ClinicalTrials.gov identifier (NCT number): NCT00514488
|Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"|
|Principal Investigator:||Michele Baccarani, MD||Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna|