Back to resultsStudy Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Primary Purpose
Chronic Myelogenous Leukemia
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Chronic Myelogenous Leukemia, Complete cytogenetic response, Imatinib mesylate, Major molecular response, Chronic phase Ph+ Chronic Myelogenous Leukemia
Eligibility Criteria
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/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STI571
Arm Description
Outcomes
Primary Outcome Measures
Percent of patients achieving major molecular response at baseline and at last visit
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00171899
First Posted
September 13, 2005
Last Updated
February 21, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00171899
Brief Title
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Official Title
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
Chronic Myelogenous Leukemia, Complete cytogenetic response, Imatinib mesylate, Major molecular response, Chronic phase Ph+ Chronic Myelogenous Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STI571
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Percent of patients achieving major molecular response at baseline and at last visit
Secondary Outcome Measure Information:
Title
Complete cytogenetic response at baseline and at last visit
Title
Overall survival
Title
Disease progression-free survival
Title
Quality of Life assessment at baseline, last visit
Title
Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Toronto
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
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