Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT03913312
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': 'Three years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Three years', 'description': 'The time from enrollment to death for any reason'}, {'measure': 'Complete Remission Rate (CR)', 'timeFrame': 'Three years', 'description': 'The proportion of cases of hematologic remission that reached the total'}, {'measure': 'Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).', 'timeFrame': 'Three years', 'description': 'Safety/Toxicity Monitoring'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML,Elderly patients,Decitabine,Unrelated cord blood'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': "Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (\\>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.", 'detailedDescription': 'A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. AML patients diagnosed by bone marrow morphology and Immunology;\n2. Exclusion of APL by Bone marrow morphology or molecular level;\n3. A patient who has obtained bone marrow cytology remission after inductive treatment;\n4. Aged from 60 to 75 years;\n5. Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT \\<2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;\n6. The function of Heart is normal;\n7. Physical condition score 0-2 (ECOG score);\n8. Get informed consent signed by patient or family member.\n\nExclusion Criteria:\n\n1. APL patients, treatment-related AML;\n2. Retreatment of patients;\n3. Allergies to any of the drugs involved in the protocol;\n4. There are obvious contraindications to chemotherapy drugs;\n5. Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;\n6. Serious heart disease, including myocardial infarction, cardiac insufficiency;\n7. Suffering from other organ malignant tumors at the same time ;\n8. Active period of tuberculosis patients and HIV-positive patients;\n9. Suffering from other blood system diseases at the same time;\n10. Pregnancy or breastfeeding;\n11. Cannot understand or follow the research plan;\n12. A history of intolerance or allergies to similar drugs;\n13. Patients under 60 years of age or over 75 years of age;\n14. Participate in other clinical researchers at the same time;\n15. There are other situations that hinder the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT03913312', 'briefTitle': 'Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly', 'orgStudyIdInfo': {'id': 'RJ-AML 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAC combined with unrelated cord blood transplantation', 'description': 'Decitabine (DAC) 15mg/m2/d, d-7 to d-3;Ara-C 1000g/m2/q12h, d-2 to d-1.Single unrelated cord blood (TNC\\>1.5\\*107/kg), d0.', 'interventionNames': ['Biological: Unrelated cord blood']}], 'interventions': [{'name': 'Unrelated cord blood', 'type': 'BIOLOGICAL', 'description': 'Unrelated cord blood comes from Shandong cord blood bank. TNC\\>1.5\\*107/kg;HLA 4-5/6', 'armGroupLabels': ['DAC combined with unrelated cord blood transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junmin Li, M.D.', 'role': 'CONTACT', 'email': 'drlijunmin@126.com'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Junmin Li', 'role': 'CONTACT', 'email': 'drlijunmin@126.com', 'phone': '86-21-64374756'}], 'overallOfficials': [{'name': 'Junmin Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiaotong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Luoyang Central Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Zhengzhou University", 'class': 'OTHER'}, {'name': "Dongguan People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Taian City Central Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University (Qingdao)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the hematology department', 'investigatorFullName': 'Li Junmin', 'investigatorAffiliation': 'Ruijin Hospital'}}}}