NCT00171158

An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis

An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

Conditions

• Philadelphia Chromosome Positive CML

Interventions

Type	Name	Description
DRUG	imatinib mesylate

Timeline

• Start date: 1999-07-26
• Primary completion: 2013-04-01
• Completion: 2013-04-22
• First posted: 2005-09-15
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

10 sites across 4 countries: United States, France, Germany, Italy

Regulatory

• FDA-regulated drug study