Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-29 @ 8:47 AM
Study NCT ID:
NCT02659657
Status:
UNKNOWN
Last Update Posted:
2020-10-01
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-15', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'II-IV acute graft-versus-host disease (aGVHD) post transplantation', 'timeFrame': 'Day 100 post transplantation', 'description': 'cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation'}], 'secondaryOutcomes': [{'measure': 'Severe chronic GVHD post transplantation', 'timeFrame': '1 year post transplantation', 'description': 'cumulative incidence of severe chronic GVHD post transplantation'}, {'measure': 'CMV infection post transplantation', 'timeFrame': 'Day 100 post transplantation', 'description': 'cumulative incidence of CMV infection post transplantation'}, {'measure': 'Measureable residual disease (MRD)-positive test post transplantation', 'timeFrame': '1 year', 'description': 'cumulative incidence of MRD+ post transplantation'}, {'measure': 'Hematological relapse post transplantation', 'timeFrame': '1 year', 'description': 'Cumulative incidence of hematological relapse post transplantation'}, {'measure': 'Disease-free free survival post transplantation', 'timeFrame': '1 year', 'description': 'Cumulative incidence of DFS post transplantation'}, {'measure': 'Overall survival post transplantation', 'timeFrame': '1 year', 'description': 'Cumulative incidence of OS post transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': 'The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.', 'detailedDescription': 'The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 15-65 years old\n2. Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT\n3. WBC engraftment (ANC\\>500/ul for continuous 3 days)\n4. At least +7d\n5. Less than or equal to +15d\n6. non T-ALL\n7. no active II-IV aGVHD\n8. no severe infections\n9. Karnofsky score greater than or equal to 90%\n10. Haploidentical donor from sibling, children or father\n11. Ensure that informed consent signed and faxed to Research Coordinator\n\nExclusion Criteria:\n\n1. Exposure to any other clinical trials prior to enrollment\n2. Active malignant disease relapses or MRD positive\n3. Active, uncontrolled infection\n4. Inability to comply with IL-2 treatment regimen\n5. Active, uncontrolled II-IV aGVHD\n6. Haploidentical donor from mother or collateral donors\n7. Clinical Signs of severe pulmonary dysfunction\n8. Clinical Signs of sever cardiac dysfunction\n9. Receiving corticosteroids as GVHD treatment'}, 'identificationModule': {'nctId': 'NCT02659657', 'briefTitle': 'Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation', 'orgStudyIdInfo': {'id': '2016PHB006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interleukin-2 interventions', 'description': 'Patients with standard risk hematologic malignancies undergoing an unmodified haploidentical HCT will be eligible. Once patients achieved neutrophil engraftment will be given IL-2, 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days).', 'interventionNames': ['Drug: Interleukin-2']}], 'interventions': [{'name': 'Interleukin-2', 'type': 'DRUG', 'otherNames': ['IL-2'], 'description': 'Interleukin-2 (IL-2), 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days)', 'armGroupLabels': ['Interleukin-2 interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangyu Zhao, M.D., PhD', 'role': 'CONTACT', 'email': 'xyz80421@126.com', 'phone': '+861088325949'}], 'facility': 'Peking University Institute of Hematology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiangyu Zhao', 'role': 'CONTACT', 'email': 'zhao_xy@bjmu.edu.cn', 'phone': '+861088324576'}, {'name': 'Xiaosu Zhao', 'role': 'CONTACT', 'email': 'zhao.xiaosu@outlook.com', 'phone': '+861088324576'}], 'overallOfficials': [{'name': 'Xiaojun Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Intitute of Hematology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Peking University Institute of Hematology', 'investigatorFullName': 'Xiaojun Huang,MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}