- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227356
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Uppsala, Sweden, S-75185
- Bengt Simonsson
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Uppsala, Sweden, S-753 20
- Uppsala University Hospital
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Uppsala, Sweden, S-75320
- Uppsala University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: imatinb + pegIntron
|
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c.
weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of rate Major Molecular Response between treatment arms
Time Frame: 2004 - 2009
|
Molecular response
|
2004 - 2009
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of complete cytogenetic response between the treatment arms at 12 months
Time Frame: 2004 - 2009
|
Cytogenetic response
|
2004 - 2009
|
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Time Frame: 2004 - 2009
|
Hematologic response
|
2004 - 2009
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: bengt NO Simonsson, MD, PhD, Uppsala University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Interferons
- Imatinib Mesylate
Other Study ID Numbers
- NordCML002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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