NCT01227356

A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia

A Randomized Study Comparing Imatinib And Imatinib/Pegylated Interferon Alpha-2B in Newly Diagnosed Non-high Risk Chronic Myeloid Leukemia Patients in Complete Hematological Remission After Imatinib Induction Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly. Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months

Detailed description

130 patients registered, 112 randomized. 56 pats in each treatment arm. 12 months study duration. Rate of Major Molecular Response was at 12 months 53 vs 82 % (p=0.002) in favour of the combination arm.

Conditions

• Health Care Quality
• Health Care Evaluation

Interventions

Type	Name	Description
DRUG	imatinib and pegylated interferon	imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-03-01
• Completion: 2009-11-01
• First posted: 2010-10-25
• Last updated: 2010-10-25

Locations

3 sites across 1 country: Sweden