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
18 Years
95 Years
Both
Health Care Quality, Health Care Evaluation
Trial Information
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
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.
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
-
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Comparison of rate Major Molecular Response between treatment arms
Outcome Description:
Molecular response
Outcome Time Frame:
2004 - 2009
Safety Issue:
Yes
Principal Investigator
bengt NO Simonsson, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Uppsala
Authority:
Sweden: Medical Products Agency
Study ID:
NordCML002
NCT ID:
NCT01227356
Start Date:
September 2004
Completion Date:
November 2009
Related Keywords:
- Health Care Quality
- Health Care Evaluation
- Chronic myeloid leukemia, imatinib, interferon
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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