Back to resultsA Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
Primary Purpose
Health Care Quality, Health Care Evaluation
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
imatinib and pegylated interferon
Sponsored by
About this trial
This is an interventional treatment trial for Health Care Quality focused on measuring Chronic myeloid leukemia, imatinib, interferon
Eligibility 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
-
Sites / Locations
- Bengt Simonsson
- Uppsala University Hospital
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
imatinb + pegIntron
Arm Description
Outcomes
Primary Outcome Measures
Comparison of rate Major Molecular Response between treatment arms
Molecular response
Secondary Outcome Measures
Comparison of complete cytogenetic response between the treatment arms at 12 months
Cytogenetic response
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Hematologic response
Full Information
NCT ID
NCT01227356
First Posted
October 22, 2010
Last Updated
October 22, 2010
Sponsor
Uppsala University
Collaborators
Uppsala University Hospital, Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01227356
Brief Title
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Uppsala University Hospital, Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Care Quality, Health Care Evaluation
Keywords
Chronic myeloid leukemia, imatinib, interferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imatinb + pegIntron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imatinib and pegylated interferon
Other Intervention Name(s)
Gleevec, PegIntron
Intervention Description
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly
Primary Outcome Measure Information:
Title
Comparison of rate Major Molecular Response between treatment arms
Description
Molecular response
Time Frame
2004 - 2009
Secondary Outcome Measure Information:
Title
Comparison of complete cytogenetic response between the treatment arms at 12 months
Description
Cytogenetic response
Time Frame
2004 - 2009
Title
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Description
Hematologic response
Time Frame
2004 - 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
bengt NO Simonsson, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Study Chair
Facility Information:
Facility Name
Bengt Simonsson
City
Uppsala
ZIP/Postal Code
S-75185
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
S-753 20
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
S-75320
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
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