Completed
PHASE3
INTERVENTIONAL
NCT00333840
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.
Interventions
Name:
imatinib mesilate
Type:
DRUG
Description:
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
Name:
interferon-alpha (INF-a)
Type:
DRUG
Description:
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
Name:
cytarabine (ARA-C)
Type:
DRUG
Description:
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
Primary Outcomes
Measure:
Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)
TimeFrame:
12,24,36,48,60,72,84,96,108,120,132 and 144 months
Description:
Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
Trial Information
NCT ID
NCT00333840
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novartis Pharmaceuticals
Last Updated
December 15, 2025