Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 12:45 PM
Study NCT ID:
NCT02317159
Status:
UNKNOWN
Last Update Posted:
2014-12-15
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of 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'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major molecular response', 'timeFrame': '2 years', 'description': 'the rate of major molecular response in two years'}], 'secondaryOutcomes': [{'measure': 'complete cytogenetics response', 'timeFrame': '1 years', 'description': 'the rate of complete cytogenetics response in one years'}, {'measure': 'over survival', 'timeFrame': '2 years', 'description': 'the rate of over survival in two years'}, {'measure': 'progress free survival', 'timeFrame': '2 years', 'description': 'the rate of progress free survival in two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age≥18；\n* The new diagnosis of CML patients in six months；\n* No proof of extra-medullary infiltration of leukemia；\n* ECOG PS score：0-2；\n* Hepatic and renal functions are normal，Serum bilirubin≤1.5\\*ULN, serum ALT and AST≤2.5\\*ULN, serum Cr≤1.5\\*ULN;\n* Do not receive the treatment of anti-CML；\n* Subjects signed informed consent form in line with GCP requirements。\n\nExclusion Criteria:\n\n* Pregnant or lactating women；\n* Received TKIs any time before；\n* Failure to control systemic infection or multiple organ failure；\n* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；\n* Being diagnosed with other malignancies in the prior 12 months；\n* Have a history of neurological or psychiatric disorders, including epilepsy or dementia；\n* Known or suspected allergy to imatinib；\n* BSA≤1.5m2；\n* Using other experimental drugs or participating in other clinical trials in the prior one months。"}, 'identificationModule': {'nctId': 'NCT02317159', 'briefTitle': 'Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cttq'}, 'officialTitle': 'Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'IMAGE-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'imatinib，Capsule', 'description': '400mg imatinib qd', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'description': '400mg imatinib qd PO', 'armGroupLabels': ['imatinib，Capsule']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhixiang Shen, Master', 'role': 'CONTACT', 'phone': '13901651262'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cttq', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}