Status:
COMPLETED
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Uppsala University Hospital
Karolinska University Hospital
Conditions:
Health Care Quality
Health Care Evaluation
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
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 mont...
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 ar...
Eligibility Criteria
Inclusion
- Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG \< 2
Exclusion
- Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG \> 2 Pregnancy
- \-
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01227356
Start Date
September 1 2004
End Date
November 1 2009
Last Update
October 25 2010
Active Locations (3)
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1
Bengt Simonsson
Uppsala, Sweden, S-75185
2
Uppsala University Hospital
Uppsala, Sweden, S-753 20
3
Uppsala University Hospital
Uppsala, Sweden, S-75320