NCT00124748

Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)

A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Conditions

• Leukemia, Myeloid, Chronic Phase

Interventions

Type	Name	Description
DRUG	Imatinib mesylate	Imatinib is packaged in bottles as 100mg and 400mg tablets

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2005-07-28
• Last updated: 2012-02-03
• Results posted: 2012-02-03

Locations

75 sites across 6 countries: United States, Argentina, Australia, Brazil, Canada, Italy