A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation

• Status: Completed
• Trial end date: 2018-09-29
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• diagnosis of CML

• Treated with at least 1 year of imatinib

• Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale confirmed during screening

• Written informed consent obtained prior to any screening procedures performed

Exclusion Criteria:

• T315I mutation

• Prior imatinib failure or had accelerated phase or blast crisis CML

• Impaired cardiac function

• Pregnant or lactating women