NCT00333840

Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,106 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	imatinib mesilate	imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
DRUG	interferon-alpha (INF-a)	interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
DRUG	cytarabine (ARA-C)	cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.

Timeline

• Start date: 2000-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2006-06-06
• Last updated: 2013-10-14
• Results posted: 2013-10-14

Locations

163 sites across 16 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom