Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06809712
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D012673', 'term': 'Semustine'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'id': 'D008130', 'term': 'Lomustine'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1-year', 'description': 'Overall survival (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.'}], 'secondaryOutcomes': [{'measure': 'Neutrophil engraftment rate', 'timeFrame': '28-days', 'description': 'The 28-day neutrophil engraftment rate is assessed, with neutrophil engraftment defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days.'}, {'measure': 'Platelet engraftment rate', 'timeFrame': '28-days', 'description': 'The 28-day platelet engraftment rate is assessed, with platelet engraftment defined as achievement of a platelet count of ≥ 20 × 10⁹/L without transfusion support for at least seven consecutive days.'}, {'measure': 'GVHD', 'timeFrame': '180 days and 2 year', 'description': 'Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.'}, {'measure': 'Relapse', 'timeFrame': '1-year', 'description': 'Cumulative incidence of disease relapse after transplantation.'}, {'measure': 'Progression-free survival', 'timeFrame': '1-year', 'description': 'Progression-free survival (PFS) after allogeneic hematopoietic cell transplantation is defined as the length of time a patient survives without evidence of disease progression or relapse following the transplantation.'}, {'measure': 'Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)', 'timeFrame': '1-year', 'description': 'Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation is defined as the time a patient survives without experiencing grade III-IV acute GVHD, severe chronic GVHD, relapse, or death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematopoietic cell transplantation', 'HLA mismatch', 'Hematologic diseases'], 'conditions': ['Hematologic Disease']}, 'descriptionModule': {'briefSummary': 'This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.', 'detailedDescription': 'This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation;\n* Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;\n* No suitable HLA matching haploidentical donor available;\n* There are suitable unrelated HLA mismatched (HLA high-resolution typing\\<9/10) donors;\n* The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.\n\nExclusion Criteria:\n\n* Patients with severe liver and kidney function (alanine aminotransferase\\>2.5 times the upper limit of normal, blood creatinine\\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction\\<50%, severe obstructive or restrictive ventilation dysfunction);\n* Merge active infections;\n* Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points;\n* Secondary tumors with merged activity;\n* Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;\n* Combine other allo hematopoietic stem cell transplantation (HSCT) contraindications.'}, 'identificationModule': {'nctId': 'NCT06809712', 'acronym': 'MIGHT', 'briefTitle': 'Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'MMU-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLA mismatch', 'description': 'Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score \\<2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.', 'interventionNames': ['Drug: Busulfan (Busulfex)', 'Drug: Cyclophosphamide (CTX)', 'Drug: Fludarabine (Fludara)', 'Drug: Semustine (MeccNU)']}], 'interventions': [{'name': 'Busulfan (Busulfex)', 'type': 'DRUG', 'description': 'Myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \\~-6d); Reduced intensity conditioning: Busulfan (Bu，3.2 mg/kg/d IV -7d\\~-5d);', 'armGroupLabels': ['HLA mismatch']}, {'name': 'Cyclophosphamide (CTX)', 'type': 'DRUG', 'description': 'Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning', 'armGroupLabels': ['HLA mismatch']}, {'name': 'Fludarabine (Fludara)', 'type': 'DRUG', 'description': 'Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \\~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d\\~-5d);', 'armGroupLabels': ['HLA mismatch']}, {'name': 'Semustine (MeccNU)', 'type': 'DRUG', 'description': 'For both myeloablative and reduced intensity conditioning:\n\nSemustine (MeCCNU: 250 mg/m2 orally-3d)', 'armGroupLabels': ['HLA mismatch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yishan Ye', 'role': 'CONTACT', 'email': 'yeyishan@zju.edu.cn', 'phone': '+86 57187236706'}, {'name': 'He Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yishan Ye, MD., PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yishan Ye, MD., PhD', 'role': 'CONTACT', 'email': 'yeyishan@hotmail.com', 'phone': '+8618268068056'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Huang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of the Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}