Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-04-13 @ 9:34 PM
Study NCT ID:
NCT02676856
Status:
UNKNOWN
Last Update Posted:
2017-12-08
First Post:
2016-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hematopoietic Stem Cell Microtransplantation for in AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2016-01-31', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CR rate', 'timeFrame': '2 years', 'description': 'The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation'}, {'measure': 'relapse rate', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 years'}, {'measure': 'Disease-free Survival', 'timeFrame': '2 years'}, {'measure': 'Incidence of chimerism', 'timeFrame': '2 years', 'description': 'Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute myeloid leukemia', 'hematopoietic stem cell microtransplantation'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '26137066', 'type': 'BACKGROUND', 'citation': 'Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).', 'detailedDescription': 'Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy\n* Intolerance or unwillingness of allogeneic HSCT\n* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study\n\nExclusion Criteria:\n\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)"}, 'identificationModule': {'nctId': 'NCT02676856', 'briefTitle': 'Hematopoietic Stem Cell Microtransplantation for in AML', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'Microtransplantation-AML-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CR group', 'description': 'For the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course.', 'interventionNames': ['Procedure: hematopoietic stem cell microtransplantation-long-term', 'Drug: Conditioning for CR group']}, {'type': 'EXPERIMENTAL', 'label': 'Non-CR group', 'description': 'For the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course.', 'interventionNames': ['Procedure: hematopoietic stem cell microtransplantation-short-term', 'Drug: Conditioning for Non-CR group']}], 'interventions': [{'name': 'hematopoietic stem cell microtransplantation-long-term', 'type': 'PROCEDURE', 'description': 'Stem cell infusion are administrated once three months for 3 times with the cell count of 3\\*10\\^8/kg/once.', 'armGroupLabels': ['CR group']}, {'name': 'hematopoietic stem cell microtransplantation-short-term', 'type': 'PROCEDURE', 'description': 'Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3\\*10\\^8/kg/once.', 'armGroupLabels': ['Non-CR group']}, {'name': 'Conditioning for CR group', 'type': 'DRUG', 'description': 'For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).', 'armGroupLabels': ['CR group']}, {'name': 'Conditioning for Non-CR group', 'type': 'DRUG', 'description': 'For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).', 'armGroupLabels': ['Non-CR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fen Huang', 'role': 'CONTACT', 'email': '13826204917@163.com', 'phone': '+86-020-62787883'}], 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fen Huang', 'role': 'CONTACT', 'email': '13826204917@163.com', 'phone': '+86-020-62787883'}], 'overallOfficials': [{'name': 'Qifa Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}