Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-28 @ 3:01 AM
Study NCT ID:
NCT05436561
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '2 year', 'description': 'survival without disease relapse or progression'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 year', 'description': 'survival'}, {'measure': 'GVHD and relapse free survival', 'timeFrame': '2 year', 'description': 'survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.'}, {'measure': 'Non-relapse mortality', 'timeFrame': '2 year', 'description': 'Death without disease progression or relapse'}, {'measure': 'Relapse', 'timeFrame': '2 year', 'description': 'disease progression or relapse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disease-free Survival']}, 'descriptionModule': {'briefSummary': 'In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \\>=55 years.', 'detailedDescription': 'Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \\>=55 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-65\n* patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.\n* patients with AML in remission, or MDS in any stage, or CMML in any stage\n* inform consent provided\n\nExclusion Criteria:\n\n* patients with abnormal liver (\\>3N), renal (1.5N) or cardiac function\n* patients with active infection'}, 'identificationModule': {'nctId': 'NCT05436561', 'briefTitle': 'Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.', 'orgStudyIdInfo': {'id': 'MBF-RIC-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBF-RIC', 'description': 'Patients with MBF-RIC as conditioning regimen', 'interventionNames': ['Drug: MBF-RIC']}], 'interventions': [{'name': 'MBF-RIC', 'type': 'DRUG', 'otherNames': ['MBF100'], 'description': 'Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan', 'armGroupLabels': ['MBF-RIC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiong HU, M.D.,', 'role': 'CONTACT', 'email': 'hujiong@medmail.com.cn', 'phone': '86-21-64370045'}, {'name': 'Ling Wang, M.D.,', 'role': 'CONTACT', 'email': 'cclingjar@163.com', 'phone': '86-21-64370045'}], 'facility': 'Blood & Marrow Transplantation Center, RuiJin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ChunKang Chang', 'role': 'CONTACT', 'email': 'changchunkang@sjtu.edu.cn', 'phone': '+862164369181'}], 'facility': 'Shanghai No 6 Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jieling Jiang', 'role': 'CONTACT', 'email': 'jiangjieling66@hotmail.com', 'phone': '+8613311986505'}, {'name': 'jiong HU', 'role': 'CONTACT', 'email': 'hj10709@rjh.com.cn', 'phone': '+8613764313546'}], 'overallOfficials': [{'name': 'Jiong Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Blood & Marrow Transplantation Center, Rui Jin Hospital', 'investigatorFullName': 'Jiong HU', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}