NCT00390897

Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia

Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses

Detailed description

Open, prospective, multicentre, phase IV, comparative and randomised study

Conditions

• Chronic Myeloid Leukaemia

Interventions

Type	Name	Description
DRUG	Glivec
DRUG	Interferon

Timeline

• Start date: 2003-07-01
• Primary completion: 2006-10-01
• Completion: 2007-12-01
• First posted: 2006-10-23
• Last updated: 2008-11-27

Locations

51 sites across 1 country: Spain