Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT01126892
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2010-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
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': 'C498826', 'term': 'nilotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.', 'timeFrame': 'between 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response', 'timeFrame': '24 months'}, {'measure': 'To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study', 'timeFrame': '24 months'}, {'measure': 'To follow loss of HR (after previous confirmed HR for AP and CHR for CP)', 'timeFrame': '3, 6 and 12 months'}]}, 'conditionsModule': {'keywords': ['Advanced Disease,', 'Resistance,', 'Intolerance'], 'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStratum 1:\n\n1. Currently participating in Novartis study CAMN107A2109\n2. Written signed and dated informed consent prior to any study procedures being performed\n\nStratum 2:\n\n1. Male or female\n2. \\> 18 years\n3. ECOG 0,1,2\n4. ASL/ALT \\<= 2.5 ULN or \\<= 5.0 ULN\n5. Alcaline Phosfatase \\<= 2.5 ULN\n6. Serum Bilirrubin \\<= 1.5 ULN\n7. Serum Creatinine \\<= 1.5 ULN or creatinine clearance \\>=50 ml/min / 24 hours\n8. Serum Lipase \\<= 1.5 ULN\n\nExclusion Criteria:\n\nStratum 1 and stratum 2:\n\n1. Reduction of the cardiac function\n2. Use of Coumadin\n3. Other severe medical concurrent conditions\n4. Treatment with medications that prolonged the QT interval.\n5. Mayor surgery 15 days before the inclusion in the protocol\n6. Pregnant women or lactation\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01126892', 'acronym': 'ENACT', 'briefTitle': 'A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase', 'orgStudyIdInfo': {'id': 'CAMN107ACO01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nilotinib', 'interventionNames': ['Drug: Nilotinib']}], 'interventions': [{'name': 'Nilotinib', 'type': 'DRUG', 'armGroupLabels': ['Nilotinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Hospital San José, Bogotá, Colombia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Banco Municipal de Sangre', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticlas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}