Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-01 @ 9:53 PM
Study NCT ID:
NCT03733834
Status:
UNKNOWN
Last Update Posted:
2018-11-07
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SD vs. NSD Therapy in Elderly AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-06', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'The time from AML diagnosis to patients death or last folloeing-up.'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': '2 years', 'description': 'The time from AML patients obtaining CR to patients relapse or last folloeing-up.'}, {'measure': 'Relapse incidence', 'timeFrame': '2 years', 'description': 'Relapsed patients account for all the diagnosed AML patients.'}, {'measure': 'Treatment-related mortality', 'timeFrame': '1 year', 'description': 'The incidence of patients dying of treatment related complication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Standard Therapy', 'Non-standard Therapy']}, 'descriptionModule': {'briefSummary': 'It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. In this multi-center study, we are going to evaluate the benefit of SD and non-SD (NSD) therapy in elder AML patients.', 'detailedDescription': 'It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced. Non-SD (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. In this multi-center study, we are going to evaluate the benefit of SD and NSD therapy in elder AML patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed AML exclusive of APL with age range from 60 years old to 75 ages old. Patients are expect to live longger than 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nNewly diagnosed AML exclusive of APL; Age from 60 years old to 75 years old.\n\nExclusion Criteria:\n\nAny abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)"}, 'identificationModule': {'nctId': 'NCT03733834', 'briefTitle': 'SD vs. NSD Therapy in Elderly AML', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Comparisiom of Standard (SD) Therapy and Non-standard (NSD) Therapy in Elderly Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'Therapy in elderly AML-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SD therapy', 'description': 'SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced.'}, {'label': 'NSD therapy', 'description': 'Non-standard (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guopan Yu', 'role': 'CONTACT', 'email': 'yugpp@163.com', 'phone': '+86-020-62787883'}], 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qifa Liu', 'role': 'CONTACT', 'email': 'liuqifa628@163.com', 'phone': '+86-20-61641615'}], 'overallOfficials': [{'name': 'Qifa Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Shenzhen Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': 'Wuhan General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Shenzhen University', 'class': 'UNKNOWN'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Zhongnan University', 'class': 'UNKNOWN'}, {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Gannan Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}