Back to resultsEfficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Primary Purpose
Chronic Myelogenous Leukemia in Chronic Phase
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia in Chronic Phase focused on measuring Chronic Myelogenous Leukemia, Imatinib, CML
Eligibility Criteria
Inclusion Criteria: Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase Previously untreated with Interferon-alpha Performance status is normal or capable of only limited self-care Exclusion Criteria: Patients who are pregnant or possibly pregnant Significant hepatic diseases Chronic Myelogenous Leukemia in advanced phase Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
3 years overall survival
Duration of remaining in chronic phase
Secondary Outcome Measures
Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00237120
Brief Title
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Official Title
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia in Chronic Phase
Keywords
Chronic Myelogenous Leukemia, Imatinib, CML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imatinib
Primary Outcome Measure Information:
Title
3 years overall survival
Title
Duration of remaining in chronic phase
Secondary Outcome Measure Information:
Title
Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Title
Adverse event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
Previously untreated with Interferon-alpha
Performance status is normal or capable of only limited self-care
Exclusion Criteria:
Patients who are pregnant or possibly pregnant
Significant hepatic diseases
Chronic Myelogenous Leukemia in advanced phase
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
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