Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT03228303
Status:
UNKNOWN
Last Update Posted:
2017-10-10
First Post:
2017-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed 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': 'C498826', 'term': 'nilotinib'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-07', 'studyFirstSubmitDate': '2017-07-16', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years', 'timeFrame': '3 years cutoff', 'description': 'Overall survival rate in years'}, {'measure': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg', 'timeFrame': '3 years cutoff', 'description': 'cholesterol level in mg'}, {'measure': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG', 'timeFrame': '3 years cutoff', 'description': 'heart state by assessment by ECG'}, {'measure': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years', 'timeFrame': '3 years cutoff', 'description': 'free survival rate in years'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP', 'detailedDescription': 'Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic phase CML not received treatment\n* Pts with no heart disease\n* Pts with no abnormal cholesterol level\n\nExclusion Criteria:\n\n* Any pts treated before with diff. Treatment\n* Pts. With past history of heart problems\n* Pts. With abnormal cholesterol level'}, 'identificationModule': {'nctId': 'NCT03228303', 'briefTitle': 'Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'Jgmaxwell'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic phase CML treated by nilotinib', 'description': 'Newly diagnosed', 'interventionNames': ['Drug: Nilotinib 150 MG [Tasigna]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic phase CML treated by imatinib', 'description': 'Newly diagnosed', 'interventionNames': ['Drug: Imatinib 400mg']}], 'interventions': [{'name': 'Nilotinib 150 MG [Tasigna]', 'type': 'DRUG', 'description': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP', 'armGroupLabels': ['Chronic phase CML treated by nilotinib']}, {'name': 'Imatinib 400mg', 'type': 'DRUG', 'description': 'Nilotinib vs imatinib in patients with newly diagnosed CML-CP', 'armGroupLabels': ['Chronic phase CML treated by imatinib']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ClinIcal professor', 'investigatorFullName': 'Jean George Maxwell', 'investigatorAffiliation': 'Assiut University'}}}}