Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT06918834
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year Disease-Free Survival (DFS) post-HSCT', 'timeFrame': '2-year', 'description': 'Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment'}], 'secondaryOutcomes': [{'measure': 'Cumulative Incidence of Allogeneic HSCT', 'timeFrame': 'The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.', 'description': 'The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.'}, {'measure': 'Complete Remission (CR) or CR Equivalent Rate from Randomization', 'timeFrame': '2-year', 'description': 'The percentage of patients achieving CR or CR equivalent, defined as the first documented occurrence.'}, {'measure': '2-year Overall Survival (OS) post-HSCT', 'timeFrame': '2-year', 'description': 'Defined as the time from HSCT to death from any cause within two years.'}, {'measure': '2-year Leukemia-Free Survival (LFS) from Randomization', 'timeFrame': '2-year', 'description': 'The time from randomization to the occurrence of disease progression, relapse, or death from any cause within two years.'}, {'measure': '2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization', 'timeFrame': '2-year', 'description': 'Defined as the assessment of patient-reported QoL starting from randomization over a 2-year period, evaluated using the EORTC QLQ-C30 questionnaire.'}, {'measure': 'Molecular Clearance Rate', 'timeFrame': '2-year', 'description': 'Molecular clearance was defined by two consecutive blood samples obtained at least 4 weeks apart after that were negative for driver mutations in a patient who had been positive before transplantation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).', 'detailedDescription': 'A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. High relapse risk MDS, defined by:\n\n * IPSS-R score ≥3.5.\n * IPSS-M stratification as intermediate-high, high, or very high risk.\n3. Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).\n4. Karnofsky Performance Status (KPS) ≥60.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Severe organ dysfunction:\n\n * Left ventricular ejection fraction \\<50%.\n * Oxygen supplementation requirement.\n * Serum bilirubin \\>1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT \\>5x upper limit of normal.\n * Estimated glomerular filtration rate (eGFR) \\<50 mL/min.\n2. History of prior allogeneic HSCT.\n3. Any condition deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT06918834', 'acronym': 'ImmBridge', 'briefTitle': 'Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial', 'orgStudyIdInfo': {'id': 'IIT2025016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate HSCT Group', 'interventionNames': ['Other: Immediate HSCT Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bridging Therapy Group', 'interventionNames': ['Other: Bridging Therapy Group']}], 'interventions': [{'name': 'Immediate HSCT Group', 'type': 'OTHER', 'description': 'Patients undergo direct allogeneic HSCT.', 'armGroupLabels': ['Immediate HSCT Group']}, {'name': 'Bridging Therapy Group', 'type': 'OTHER', 'description': 'Patients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT.\n\no Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients.', 'armGroupLabels': ['Bridging Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijin', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Jiang', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital"}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'weijie cao', 'role': 'CONTACT', 'email': '945509679@qq.com', 'phone': '+86-15093360671'}], 'facility': 'Zhengzhou University First Affiliated Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'FANG ZHOU', 'role': 'CONTACT', 'phone': '+86-13969179221'}], 'facility': "The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army", 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '610083', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'hai yi', 'role': 'CONTACT', 'email': 'yihaimail@163.com', 'phone': '+86-17760428229'}, {'name': 'yan deng', 'role': 'CONTACT', 'email': '285924840@qq.com', 'phone': '+86-15828495714'}], 'facility': "People's Liberation Army The General Hospital of Western Theater Command", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Shijia Zhuang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuxu Wang', 'role': 'CONTACT', 'email': 'wfxhebmu@163.com', 'phone': '+86-13931100360'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 34.17775, 'lon': 109.84894}}], 'centralContacts': [{'name': 'Jiang Erlie, doctor', 'role': 'CONTACT', 'email': 'jiangerlie@ihcams.ac.cn', 'phone': '+86-15122538106'}, {'name': 'Xiao Zhijian, doctor', 'role': 'CONTACT', 'email': 'xiaozhijian@ihcams.ac.cn', 'phone': '+86-13821085716'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}