Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT03600558
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2018-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of FLAG Regimen for the Treatment of Patients With AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'For evaluating the FLAG effect, OS was defined from consolidation randomization to death from any cause (censored at last contact).'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': '2 years', 'description': 'Relapse Free Survival defined as the time from onset of FLAG treatment for AML to the first event (death or relapse).'}, {'measure': 'Severe adverse events', 'timeFrame': '45 days', 'description': 'Severe adverse events during consolidation treatment'}, {'measure': 'Complete Remission Rate', 'timeFrame': '2 months'}, {'measure': 'Event-Free Survival Rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FLAG'], 'conditions': ['Leukemia', 'Leukemia, Myeloid', 'Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': 'The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective cohort, using medical charts of AML patients treated with the FLAG regimen from January 2007 to May 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient more than 18 year old\n* De novo or secondary leukemia.\n* Treated with FLAG regimen\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL)'}, 'identificationModule': {'nctId': 'NCT03600558', 'briefTitle': 'Efficacy of FLAG Regimen for the Treatment of Patients With AML', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'Handong'}}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zonghong Shao, MD', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zonghong Shao, MD', 'role': 'CONTACT', 'email': 'shaozonghong@sina.com', 'phone': '8602260817092'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of department of Hematology', 'investigatorFullName': 'ZhongHong Shao', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}