Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04713956
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-relapse mortality (NRM)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '1 year'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': '1 year'}, {'measure': 'Relapse rate', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndrome', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'Conditioning']}, 'descriptionModule': {'briefSummary': 'Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.', 'detailedDescription': 'Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT\n* 14-65 years\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': 'NCT04713956', 'briefTitle': 'G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'DAC+BUCY vs DAC+BF-MDS-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF+DAC+BF', 'description': 'For patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo- HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3.', 'interventionNames': ['Drug: Granulocyte Colony-Stimulating Factor(G-CSF)', 'Drug: Decitabine (DAC)', 'Drug: Busulfan (BU)', 'Drug: Fludarabine (FLU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G-CSF+DAC+BUCY', 'description': 'For patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo- HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 to -2.', 'interventionNames': ['Drug: Granulocyte Colony-Stimulating Factor(G-CSF)', 'Drug: Decitabine (DAC)', 'Drug: Busulfan (BU)', 'Drug: Cyclophosphamide (CY)']}], 'interventions': [{'name': 'Granulocyte Colony-Stimulating Factor(G-CSF)', 'type': 'DRUG', 'description': 'G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.', 'armGroupLabels': ['G-CSF+DAC+BF', 'G-CSF+DAC+BUCY']}, {'name': 'Decitabine (DAC)', 'type': 'DRUG', 'description': 'Decitabine was administered at 20mg/m2/day on days -14 to -10.', 'armGroupLabels': ['G-CSF+DAC+BF', 'G-CSF+DAC+BUCY']}, {'name': 'Busulfan (BU)', 'type': 'DRUG', 'description': 'Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .', 'armGroupLabels': ['G-CSF+DAC+BF', 'G-CSF+DAC+BUCY']}, {'name': 'Cyclophosphamide (CY)', 'type': 'DRUG', 'description': 'Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.', 'armGroupLabels': ['G-CSF+DAC+BUCY']}, {'name': 'Fludarabine (FLU)', 'type': 'DRUG', 'description': 'Fludarabine was administered at 30 mg/m2/day on days -7 to -3.', 'armGroupLabels': ['G-CSF+DAC+BF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Xuan', 'role': 'CONTACT', 'email': '356135708@qq.com', 'phone': '+86-020-62787883'}, {'name': 'Qifa Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Li Xuan', 'role': 'CONTACT', 'email': '356135708@qq.com', 'phone': '+86-020-62787883'}], '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': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "First People's Hospital of Chenzhou", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}