Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-01 @ 2:09 PM
Study NCT ID:
NCT03654703
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Post-Transplant Cyclophosphamide Regimens for Pediatric Patients With Refractory AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease status', 'timeFrame': '1 year', 'description': 'Disease status can be measured by test the of (minimal residual disease) MRD via flow cytometry one time each month until one year after HSCT. MRD\\<0.0001 （complete remission), if not, relapse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSCT, AML， R-AML'], 'conditions': ['Hematopoietic System--Cancer']}, 'referencesModule': {'references': [{'pmid': '30087460', 'type': 'RESULT', 'citation': 'Sugita J, Kagaya Y, Miyamoto T, Shibasaki Y, Nagafuji K, Ota S, Furukawa T, Nara M, Akashi K, Taniguchi S, Harada M, Matsuo K, Teshima T; Japan Study Group for Cell Therapy and Transplantation (JSCT). Myeloablative and reduced-intensity conditioning in HLA-haploidentical peripheral blood stem cell transplantation using post-transplant cyclophosphamide. Bone Marrow Transplant. 2019 Mar;54(3):432-441. doi: 10.1038/s41409-018-0279-1. Epub 2018 Aug 7.'}, {'pmid': '30041010', 'type': 'RESULT', 'citation': 'Marani C, Raiola AM, Morbelli S, Dominietto A, Ferrarazzo G, Avenoso D, Giannoni L, Varaldo R, Gualandi F, Grazia D, Lamparelli T, Bregante S, Van Lint MT, Ibatici A, Bovis F, Lemoli RM, Gobbi M, Bacigalupo A, Angelucci E. Haploidentical Transplants with Post-Transplant Cyclophosphamide for Relapsed or Refractory Hodgkin Lymphoma: The Role of Comorbidity Index and Pretransplant Positron Emission Tomography. Biol Blood Marrow Transplant. 2018 Dec;24(12):2501-2508. doi: 10.1016/j.bbmt.2018.07.025. Epub 2018 Jul 21.'}, {'pmid': '30009980', 'type': 'RESULT', 'citation': 'Law AD, Salas MQ, Lam W, Michelis FV, Thyagu S, Kim DDH, Lipton JH, Kumar R, Messner H, Viswabandya A. Reduced-Intensity Conditioning and Dual T Lymphocyte Suppression with Antithymocyte Globulin and Post-Transplant Cyclophosphamide as Graft-versus-Host Disease Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplants for Hematological Malignancies. Biol Blood Marrow Transplant. 2018 Nov;24(11):2259-2264. doi: 10.1016/j.bbmt.2018.07.008. Epub 2018 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'No more datas about post-transplant cyclophosphamide (PT/Cy) used in pediatric refractory acute myeloid leukemia (R-AML）patients. Investigators reasoned that this group of patients if they have been treated with ablative conditioning regimens for HSCT combined with PT/Cy, under the rapid of immune reconstitution will have better outcomes.', 'detailedDescription': "Haploidentical stem cell transplantation (HSCT) is a potentially curative therapy for patients with high risk or refractory acute myeloid leukemia (R-AML). Graft-versus-host disease （GVHD）is a major barrier to achieve success for patients with HSCT. High dose cyclophosphamide given after HLA-matched related and unrelated allogeneic stem cell transplantation for patients with hematologic malignancies is effective single agent (GVHD) prophylaxis in adults and in pediatric benign patients. Data describing outcomes for pediatric maligant patients has not been reported. Investigators have recruited 26 pediatric patients (3 years \\< age \\<18 years) between March 2015 to July 2018 with primary induction R-AML treated in investigators' institution for R-AML with modified myeloablative regimen, post-transplant cyclophosphamide (PTCy) has been used as GVHD prophylaxis.\n\nConditioning regimen of the group of patient consisted Idrabine(IDA,10mg/m2/day) which was administered intravenously for 2 days, from days -14 to -13, total body irritation (TBI, 9 Gy) which was divided into 3 fractions and 3 days from -12 to -10, thymoglobulin (2.5mg/kg/day) was administered for 3 days, from -9 to -7, etoposide (VP-16, 300mg/m2) which was infused intravenously on day -6, cladribine (10mg/m2/day) which was administered for 3 days from -5 to -2 ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-refractory AML\n\nExclusion Criteria:\n\n\\- complete remission AML'}, 'identificationModule': {'nctId': 'NCT03654703', 'briefTitle': 'Improved Post-Transplant Cyclophosphamide Regimens for Pediatric Patients With Refractory AML', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Capital Research Institute of Pediatrics'}, 'officialTitle': 'Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CIP-2015-AML'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclophophamide', 'description': 'Cyclophosphamide 50mg/kg/day on day+3，+4 after HSCT. Intervention: drugs:Cyclophosphamide.', 'interventionNames': ['Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': '5% GLS（Placebo) 50ml/day on day+3，+4 after HSCT. Intervention: drugs: Placebo other name: placebo (for Cyclophosphamide) 5%Glugose in water 50ml or normal saline', 'interventionNames': ['Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cy'], 'description': 'cyclophophamide', 'armGroupLabels': ['Cyclophophamide', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Chaoyang District', 'country': 'China', 'facility': 'Yan Yue', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jia Y Qin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hematology and oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Research Institute of Pediatrics', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Yan Yue', 'investigatorAffiliation': 'Capital Research Institute of Pediatrics'}}}}