Chronic Myelogenous Leukemia
Conditions
Keywords
Chronic Myelogenous Leukemia, Complete cytogenetic response, Imatinib mesylate, Major molecular response, Chronic phase Ph+ Chronic Myelogenous Leukemia
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 of the level of chronic myelogenous leukemia) versus the standard dose.
Interventions
DRUGimatinib mesylate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients achieving major molecular response at baseline and at last visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete cytogenetic response at baseline and at last visit | — |
| Overall survival | — |
| Disease progression-free survival | — |
| Quality of Life assessment at baseline, last visit | — |
| Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications | — |
Countries
Canada
Outcome results
None listed