Status:
COMPLETED
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Must have signed consent for Amendment 5
- Must have completed visit 62 of the core IRIS trial or be in follow-up
- Must be on STI571 treatment
- If on IFN treatment, must be willing to cross over to STI571 treatment
- Exclusion criteria:
- Patients who have discontinued from the study and are in follow-up
- Patients who are on IFN treatment and do not want to cross over to STI571 treatment
- Patients who have not consented to amendment 5
- Patients who did not complete the amendment 5 protocol
- Additional protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
1106 Patients enrolled
Trial Details
Trial ID
NCT00333840
Start Date
June 1 2000
End Date
March 1 2012
Last Update
October 14 2013
Active Locations (163)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294
2
Novartis Investigative Site
Montgomery, Alabama, United States, 36106
3
Novartis Investigative Site
Tucson, Arizona, United States, 85724
4
Novartis Investigative Site
Berkeley, California, United States, 94704