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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cytarabine; Imatinib Mesylate; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

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