Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Phase 3
15 Years
74 Years
15 Years
74 Years
Not Enrolling
Both
Chronic Myelogenous Leukemia in Chronic Phase
Both
Chronic Myelogenous Leukemia in Chronic Phase
Trial Information
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 years overall survival
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CSTI571AJP02
NCT ID:
NCT00237120
Start Date:
November 2002
Completion Date:
June 2007
Related Keywords:
- Chronic Myelogenous Leukemia in Chronic Phase
- Chronic Myelogenous Leukemia
- Imatinib
- CML
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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