Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-09 @ 10:42 PM
Study NCT ID:
NCT05921318
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-06-19', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event', 'timeFrame': 'Participants will be followed for an expected average of 1 years', 'description': 'The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation'}, {'measure': 'Engraftment rate', 'timeFrame': 'Participants will be followed for an expected average of 1 years', 'description': 'The success rate of engraftment after transplantation'}], 'primaryOutcomes': [{'measure': '1-year LFS', 'timeFrame': 'Participants will be followed for an expected average of 1 years', 'description': 'defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.'}], 'secondaryOutcomes': [{'measure': '1-year OS', 'timeFrame': 'Participants will be followed for an expected average of 1 years', 'description': 'defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.'}, {'measure': '1-year TRM', 'timeFrame': 'Participants will be followed for an expected average of 1 years', 'description': 'defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allogenetic hematopoietic stem cell transplant', 'HLA locus', 'Hematologic Malignancy'], 'conditions': ['Hematologic Malignancy', 'Stem Cell Transplant Complications']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.', 'detailedDescription': 'Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hematologic malignancy patients\n* patients eligible for the transplantation of allogeneic hematopoietic stem cells;\n* patients unavailable with HLA matched donor or related haploidentical donor\n* voluntary participation in this study and signing the informed consent form.\n\nExclusion Criteria:\n\n* Patients with the severe infections;\n* Pregnant or lactating women\n* Patients who are not eligible for hematopoietic stem cell transplantation;\n* Patients who are enrolled in other clinical trials within 1 month;\n* Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;\n* Patients unable to properly understand or refusing to accept the informed consent form.'}, 'identificationModule': {'nctId': 'NCT05921318', 'briefTitle': 'Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT', 'orgStudyIdInfo': {'id': 'Highly HLA mismatched HSCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'more than 5/10 HLA-mismatched allo-HSCT', 'description': 'more than 5/10 HLA-mismatched allo-HSCT', 'interventionNames': ['Combination Product: Beijing protocol']}], 'interventions': [{'name': 'Beijing protocol', 'type': 'COMBINATION_PRODUCT', 'description': 'For patients \\<55 years and HCT-CI≤ 3：Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6 days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days)\n\nFor patients ≥ 55 years or HCI-CI\\>3：Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days).', 'armGroupLabels': ['more than 5/10 HLA-mismatched allo-HSCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Huang, doctor', 'role': 'CONTACT', 'email': 'xjrm@medmail.com.cn', 'phone': '8601088326666'}, {'name': 'Xiaojun Huang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Deparment of Hematology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yu Wang, Prof.', 'role': 'CONTACT', 'email': 'ywyw3172@sina.com', 'phone': '13552647384'}], 'overallOfficials': [{'name': 'Xiaojun Huang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "director, hematology department,Peking University People's Hospital", 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}