Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06362967
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment', 'timeFrame': 'at the end of desensitation treatment', 'description': 'Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Incidence of primary graft failure', 'timeFrame': '42 days', 'description': 'Incidence of primary graft failure'}, {'measure': 'Incidence of TRM after allo-HSCT', 'timeFrame': '100 days', 'description': 'Incidence of TRM after allo-HSCT'}, {'measure': 'Incidence of ineffective platelet transfusion after allo-HSCT', 'timeFrame': '100 days', 'description': 'Incidence of ineffective platelet transfusion after allo-HSCT'}, {'measure': 'Cumulative incidence of neutrophil engraftment after allo-HSCT', 'timeFrame': '42 dyas', 'description': 'Cumulative incidence of neutrophil engraftment after allo-HSCT cumulative incidence of neutrophil engraftment after allo-HSCT'}, {'measure': 'Cumulative incidence of II-IV° acute GVHD', 'timeFrame': '100 days', 'description': 'Cumulative incidence of II-IV° acute GVHD'}, {'measure': 'Cumulative incidence of relapse at 1 year post-transplant', 'timeFrame': '360 days', 'description': 'Cumulative incidence of relapse at 1 year post-transplant'}, {'measure': 'Probability of overall survival post transplantation', 'timeFrame': '360 days', 'description': 'Probability of overall survival post transplantation'}, {'measure': 'Incidence of allergies and allergic reactions', 'timeFrame': 'at the end of desensitation treatment', 'description': 'Incidence of allergies and allergic reactions'}, {'measure': 'Incidence of haemorrhagic events', 'timeFrame': 'at the end of desensitation treatment', 'description': 'Incidence of haemorrhagic events'}, {'measure': 'Incidence of viral, bacterial and fungal infections', 'timeFrame': 'at the end of desensitation treatment', 'description': 'Incidence of viral, bacterial and fungal infections'}, {'measure': 'Incidence of hypocalcaemia', 'timeFrame': 'at the end of desensitation treatment', 'description': 'Incidence of hypocalcaemia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunoadsorption or plasma exchange；rituximab；high-dose IVIG'], 'conditions': ['High Titers of Anti-HLA Antibody (MFI ≥5000)']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation', 'detailedDescription': "Approximately 10-21% of allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients have non-specific or donor-specific anti-HLA antibodies (DSAs) prior to transplantation. Patients with combined DSAs and mean fluorescence intensity (MFI) ≥ 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation, and increased transplant-related mortality (TRM). Meanwhile, a retrospective study at our centre found that patients with high titre non-specific antibodies (MFI ≥ 5000) present before cord blood transplantation had significantly higher TRM in the early post-transplantation period. Therefore, our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patient's body, reduce the incidence of transplant-related complications, and improve the prognosis of transplantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects to undergo allo-HSCT\n2. Age 14-60, No gender, No ethnicity\n3. ECOG score ≤ 2\n4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000\n5. No severe organ failure and no active infections\n6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form\n\nExclusion Criteria:\n\n1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas\n2. Pregnancy\n3. Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment\n4. Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk\n5. Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction\n6. Participants in other clinical studies within 3 months\n7. Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)'}, 'identificationModule': {'nctId': 'NCT06362967', 'briefTitle': 'The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study', 'orgStudyIdInfo': {'id': 'Anti-HLA antibody'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'antibody desensitisation group', 'description': 'Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG', 'interventionNames': ['Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG']}], 'interventions': [{'name': 'Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Intravenous Immunoglobin'], 'description': 'For allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation.', 'armGroupLabels': ['antibody desensitisation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230036', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyu Zhu, ph.D', 'role': 'CONTACT', 'email': 'xiaoyuz@ustc.cn', 'phone': '15255456091'}, {'name': 'Yue Wu, M.D', 'role': 'CONTACT', 'email': 'wuyue20160701@163.com', 'phone': '13805601119'}], 'facility': 'The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Xiaoyu Zhu, ph.D.', 'role': 'CONTACT', 'email': 'xiaoyuz@ustc.edu.cn', 'phone': '15255456091'}, {'name': 'Yue Wu, M.D.', 'role': 'CONTACT', 'email': '287109658@qq.com', 'phone': '13805601119'}], 'overallOfficials': [{'name': 'Xiaoyu Zhu, ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}