Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-27 @ 5:00 AM
Study NCT ID:
NCT05807659
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission 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': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival of this group of patients at the end of 2 year'}], 'secondaryOutcomes': [{'measure': 'Non-relapse mortality (NRM)', 'timeFrame': '6 months', 'description': 'Non-relapse mortality of this group of patients at the end of 6 months'}, {'measure': 'Relapse rate', 'timeFrame': '2 years', 'description': 'Relapse rate of this group of patients at the end of 2 year'}, {'measure': 'Cumulative incidence of acute graft versus host disease (aGVHD)', 'timeFrame': 'Day +100', 'description': 'Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100'}, {'measure': 'Cumulative incidence of chronic graft versus host disease (cGVHD)', 'timeFrame': '2 years', 'description': 'Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myeloid malignancies', 'allo-HSCT'], 'conditions': ['Myeloid Malignancies']}, 'descriptionModule': {'briefSummary': 'The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are:\n\n* The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT.\n* The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT.\n\nParticipants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\\~-3, fludarabine 35mg/m2 d-6\\~-2, cytarabine 1g/m2,d-6\\~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);\n2. KPS score \\> 60 or ECOG score 0-2;\n3. The expected survival period \\> 3 months;\n4. Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%.\n5. Those who have no central nervous system involvement or serious functional damage to important organs of the body;\n6. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;\n\nExclusion Criteria:\n\n1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;\n2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;\n3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;\n4. Combined with other malignant tumors and require treatment;\n5. Pregnant or lactating females;\n6. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;\n7. Patients with active chronic hepatitis B or active hepatitis C;\n8. History of prolonged QT syndrome;\n9. Patients considered by other researchers to be unsuitable for this study'}, 'identificationModule': {'nctId': 'NCT05807659', 'briefTitle': 'Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'Fractionated Busulfan Combined With Chidamide/Fludarabine/Cytarabine (ChiFAB) With Allogeneic Hematopoietic Stem-Cell Transplantation in Non-remission Myeloid Malignancies: a Phase II Study', 'orgStudyIdInfo': {'id': 'Fra-Bu 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fractionated busulfan', 'description': 'fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\\~-3, fludarabine 35mg/m2 d-6\\~-2 cytarabine 1g/m2,d-6\\~-2 chidamide 30mg d-13,-10,-6,-3', 'interventionNames': ['Drug: fractionated busulfan-based conditioning regimen']}], 'interventions': [{'name': 'fractionated busulfan-based conditioning regimen', 'type': 'DRUG', 'description': 'Drug: Chidamide 30 mg oral twice weekly for 2 weeks Drug: Fludarabine 35 mg/m2 intravenously daily for 5 days in the 2nd week Drug: Cytarabine\n\n1 g/m2 intravenously for 5 days in the 2nd week Drug: Busulfan 3.2 mg/kg intravenously daily for 2 days in the 1st week, 1.6 mg/kg intravenously daily for 4 days in the 2nd week Procedure/Surgery: allogeneic hematopoietic stem cell transplantation', 'armGroupLabels': ['fractionated busulfan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Ji, MD', 'role': 'CONTACT', 'email': 'jijie@wchscu.cn', 'phone': '86-28-85422370'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after the publication of results of this trial', 'ipdSharing': 'YES', 'description': 'Release after the publication of results of this trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jie Ji', 'investigatorAffiliation': 'Sichuan University'}}}}