Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Uppsala University
Collaborators:
Karolinska University Hospital
Uppsala University Hospital
Treatments:
Imatinib Mesylate
Interferons
Peginterferon alfa-2b
Criteria
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

-