Health Care Quality Clinical Trial
Official title:
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
Verified date | October 2010 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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
Status | Completed |
Enrollment | 112 |
Est. completion date | November 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2 Exclusion Criteria: Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Bengt Simonsson | Uppsala | |
Sweden | Uppsala University Hospital | Uppsala | |
Sweden | Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Karolinska University Hospital, Uppsala University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of rate Major Molecular Response between treatment arms | Molecular response | 2004 - 2009 | Yes |
Secondary | Comparison of complete cytogenetic response between the treatment arms at 12 months | Cytogenetic response | 2004 - 2009 | Yes |
Secondary | Comparison rate complete cytogenetic response between the treatment arms at 12 months | Hematologic response | 2004 - 2009 | Yes |
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