Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-02 @ 5:48 AM
Study NCT ID:
NCT00430066
Status:
COMPLETED
Last Update Posted:
2014-10-08
First Post:
2007-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Imatinib Mesylate in Polycythemia Vera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-07', 'studyFirstSubmitDate': '2007-01-31', 'studyFirstSubmitQcDate': '2007-01-31', 'lastUpdatePostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Haematocrit to less than 45%.', 'timeFrame': '6-12 months'}], 'secondaryOutcomes': [{'measure': 'Response duration', 'timeFrame': '6-12 months'}, {'measure': 'Safety profile', 'timeFrame': '6-12 months'}, {'measure': 'Reduction in platelet count and spleen size', 'timeFrame': '6-12 months'}, {'measure': 'Reduction of incidence phlebotomies.', 'timeFrame': '6-12 months'}, {'measure': 'Symptoms improvement in patients.', 'timeFrame': '6-12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycythemia Vera']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.\n\nThe patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.', 'detailedDescription': 'Hematocrit \\<45% in men or \\<42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea\n* Age \\>18 years\n* Signed written informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Creatinine \\>3 max NV\n* Bilirubin \\>3 max NV\n* AST/ALT \\>3 max NV\n* Concomitant and severe psychiatric disorder\n* Concomitant neoplastic disease'}, 'identificationModule': {'nctId': 'NCT00430066', 'briefTitle': 'Effects of Imatinib Mesylate in Polycythemia Vera', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera', 'orgStudyIdInfo': {'id': 'CSTI571POLIVERA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imatinib Mesylate', 'description': '400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)', 'interventionNames': ['Drug: Imatinib Mesylate']}], 'interventions': [{'name': 'Imatinib Mesylate', 'type': 'DRUG', 'description': '400 mg/die for 6 months', 'armGroupLabels': ['Imatinib Mesylate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enrica Morra, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Divisione di Ematologia - Ospedale Niguarda Ca' Granda"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}