A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
- Conditions
- Health Care QualityHealth Care Evaluation
- Interventions
- Registration Number
- NCT01227356
- Lead Sponsor
- Uppsala University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2
Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description imatinb + pegIntron imatinib and pegylated interferon -
- Primary Outcome Measures
Name Time Method Comparison of rate Major Molecular Response between treatment arms 2004 - 2009 Molecular response
- Secondary Outcome Measures
Name Time Method Comparison of complete cytogenetic response between the treatment arms at 12 months 2004 - 2009 Cytogenetic response
Comparison rate complete cytogenetic response between the treatment arms at 12 months 2004 - 2009 Hematologic response
Trial Locations
- Locations (2)
Bengt Simonsson
🇸🇪Uppsala, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Bengt Simonsson🇸🇪Uppsala, Sweden