NCT00514969

Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase

Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase. A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive additional therapy during Part 2 of the trial provided that, in the opinion of the investigator, the patient has benefited from treatment with STI571 and in the absence of safety concerns. During Part 2 (which is of indefinite duration), patients will continue to receive STI571 on a daily basis until either death, the development of intolerable toxicity or the investigator feels it is no longer in the patient's best interest to continue therapy, whichever comes first.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Imatinib (STI571)

Timeline

• Start date: 2000-08-01
• First posted: 2007-08-10
• Last updated: 2007-08-10

Locations

1 site across 1 country: Italy