NCT00171223

An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.

Conditions

• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Type	Name	Description
DRUG	STI571	STI571 oral capsules or tablets.

Timeline

• Start date: 1999-12-06
• Primary completion: 2013-11-29
• Completion: 2013-11-29
• First posted: 2005-09-15
• Last updated: 2021-07-22
• Results posted: 2021-07-22

Locations

28 sites across 6 countries: United States, France, Germany, Italy, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study