Status:
COMPLETED
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure...
Eligibility Criteria
Inclusion
- Chronic myelogenous leukemia with Philadelphia chromosome
- 18 years and older
- Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.
Exclusion
- Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
- Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
- Patients with other current primary malignancy or malignancy requiring active intervention
- Other protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00171899
Start Date
April 1 2005
End Date
June 1 2007
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Investigative Site
Toronto, Canada