Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT07085156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Intensity Conditioning for MDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D002066', 'term': 'Busulfan'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year relapse-free survival after transplantation', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'relapse'}], 'secondaryOutcomes': [{'measure': '2-year post-transplant survival', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'survival'}, {'measure': 'Cumulative recurrence rate at 2 years post-transplant', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'relapse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDS', 'Reduced intensity conditioning'], 'conditions': ['MDS']}, 'descriptionModule': {'briefSummary': 'Allogeneic hematopoietic cell transplantation (allo-HCT) is the only potential cure for Myelodysplastic syndrome (MDS). Currently, the conditioning regimen for MDS allogeneic transplantation still follows AML, and there are fewer explorations in this field. In a large-scale retrospective analysis with 532 MDS undergoing allo-HCT, reduced intensity conditioning is resulted in improved overall survival (OS), reduced non-relapse mortality (NRM) , while sparing relapse.\n\nTherefore, the investigators conduct a prospective, single-arm, multicentre study to evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan reduced-intensity conditioning in MDS patients.', 'detailedDescription': 'This study is a prospective, multicenterstudy designed to evaluate the efficacy and safety of evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan intermediate-intensity transplantation conditioning regimen for the treatment of MDS. . Patients with MDS who are eligible for enrolment were pretreated with a Fludarabine-Melphalan-Busulfan regimen (Fludarabine 30mg/m2d-6 to -2; melphalan 70mg/m2d-6; busulfan 3.2mg/kg d-4 to -3). The primary endpoint is 2-year relapse-free survival (RFS) after transplantation. Secondary endpoints includes 2-year post-transplant survival (OS) and cumulative recurrence rate at 2 years post-transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 14-70 (including boundaries) and gender;\n* Diagnosis of MDS is confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;\n* IPSS-R intermediate-risk or higher-risk or IPSS-M intermediate-risk or higher-risk MDS; transfusion-dependent MDS;\n* ECOG score≤ 3 points;\n* Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:\n* Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN);\n* Alanine aminotransferase (ALT) ≤ 3x ULN;\n* Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;\n* Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;\n* Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;\n* Left ventricular ejection fraction (LVEF) ≥50%;\n* Voluntarily signing the informed consent, understanding and complying with the requirements of the study, good compliance, and cooperating with the follow-up visits.\n\nExclusion Criteria:\n\n* Allergies or contraindications to any of the drugs in the protocol;\n* Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;\n* Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);\n* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;\n* Patients with neurological or psychiatric disorders;\n* The patient is pregnant or breastfeeding;\n* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.\n* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;"}, 'identificationModule': {'nctId': 'NCT07085156', 'briefTitle': 'Reduced Intensity Conditioning for MDS', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Efficacy and Safety of Reduced-Intensity Conditioning With Fludarabine- Melphalan-Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'RJ-BMT-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FBM arm', 'description': 'Adult MDS patients eligible for allo-HCT will receive Fludarabine 30mg/m\\^2 d-6 to -2; melphalan 70mg/m\\^2 d-6; busulfan 3.2mg/kg d-4 to -3 as conditioning regimen.', 'interventionNames': ['Drug: Fludarabine; melphalan; busulfan']}], 'interventions': [{'name': 'Fludarabine; melphalan; busulfan', 'type': 'DRUG', 'description': 'The conditioning regimen includes fludarabine, busulfan, and melphalan, with a transplant conditioning intensity of 3.0. The RIC is used in the allo-HCT in the MDS patients.', 'armGroupLabels': ['FBM arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaoxia HU, Doctor', 'role': 'CONTACT', 'email': 'hu_xiaoxia@126.com', 'phone': '02164370045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuhan TongJi Hospital', 'class': 'OTHER'}, {'name': "Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology", 'class': 'UNKNOWN'}, {'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hu Xiaoxia', 'investigatorAffiliation': 'Ruijin Hospital'}}}}