Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-01-01 @ 1:55 PM
Study NCT ID:
NCT07029958
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of aGVHD', 'timeFrame': 'post-HSCT 100days'}], 'secondaryOutcomes': [{'measure': 'Incidence of TMA', 'timeFrame': 'post-HSCT 1year'}, {'measure': 'Incidence of VOD', 'timeFrame': 'post-HSCT 1year'}, {'measure': 'Overall survival', 'timeFrame': 'post-HSCT 1year'}, {'measure': 'Incidence of adverse events', 'timeFrame': '30 days after discontinuation of medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['EBV-T/NK LPD']}, 'descriptionModule': {'briefSummary': 'To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as poor engraftment, thrombotic microvascular disease, early EBV reactivation and relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria\n* Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital\n* Age ≤ 18 years old\n* Sign informed consent form\n* Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 \\^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)\\<10mg/kg\n\nExclusion Criteria:\n\n* The expected survival period for multiple organ failure is no more than 3 months\n* Not signing the informed consent form'}, 'identificationModule': {'nctId': 'NCT07029958', 'briefTitle': 'Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease', 'orgStudyIdInfo': {'id': '[2024]-Y-254-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'interventionNames': ['Drug: recombinant humanized anti-CD25 monoclonal antibody']}], 'interventions': [{'name': 'recombinant humanized anti-CD25 monoclonal antibody', 'type': 'DRUG', 'description': 'For children at high risk of GVHD, one of the following conditions must be met (haploidentical donors must meet one condition, while unrelated donors must meet two conditions):\n\n1. The donor is ≥40 years old;\n2. The donor is an unrelated donor with ≥1 locus mismatch, a haploidentical female donor, or collateral consanguinity (e.g., cousin, uncle/aunt);\n3. Pre-transplant CD3 count ≥4 x 10\\^8/kg;\n4. The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase;\n5. ATG (or biologically equivalent doses of ATLG \\[1:2\\] or ALG \\[1:20\\]) \\<10mg/kg. Combining recombinant anti-CD25 humanized monoclonal antibody with conventional pretreatment regimen, before peripheral blood stem cell transfusion (i.e. 0d) and+3d, 1mg/kg，\\<40kg the maximum dose should not exceed25mg/dose, ≥40kg 1mg/kg, and the maximum dose should not exceed 50mg/dose.', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Yang', 'role': 'CONTACT', 'email': 'yangjundabby@outlook.com', 'phone': '+8601059612403'}], 'facility': "Beijing Children's Hospital Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Yang', 'role': 'CONTACT', 'email': 'yangjundabby@outlook.com', 'phone': '+86 01059612403'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The research results will be published in the form of an article in the future. Depending on the circumstances of the study, it may be possible to provide the relevant data upon request via email or other means.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Jun Yang', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}