Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01227356
Status:
COMPLETED
Last Update Posted:
2010-10-25
First Post:
2010-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-22', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of rate Major Molecular Response between treatment arms', 'timeFrame': '2004 - 2009', 'description': 'Molecular response'}], 'secondaryOutcomes': [{'measure': 'Comparison of complete cytogenetic response between the treatment arms at 12 months', 'timeFrame': '2004 - 2009', 'description': 'Cytogenetic response'}, {'measure': 'Comparison rate complete cytogenetic response between the treatment arms at 12 months', 'timeFrame': '2004 - 2009', 'description': 'Hematologic response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic myeloid leukemia, imatinib, interferon'], 'conditions': ['Health Care Quality', 'Health Care Evaluation']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG \\< 2\n\nExclusion Criteria:\n\nLes than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG \\> 2 Pregnancy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01227356', 'briefTitle': 'A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NordCML002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'imatinb + pegIntron', 'interventionNames': ['Drug: imatinib and pegylated interferon']}], 'interventions': [{'name': 'imatinib and pegylated interferon', 'type': 'DRUG', 'otherNames': ['Gleevec', 'PegIntron'], 'description': 'imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly', 'armGroupLabels': ['imatinb + pegIntron']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Bengt Simonsson', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'S-753 20', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'S-75320', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'bengt NO Simonsson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Bengt Simonsson/Professor', 'oldOrganization': 'Uppsala University'}}}}