Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT06362720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with CMV infection and reactivation', 'timeFrame': '14 days to 6 months after transplant', 'description': 'Number of participants with CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen'}], 'secondaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'at 2 years after transplant'}, {'measure': 'Median overall survival', 'timeFrame': 'at 2 years after transplant'}, {'measure': 'cumulative incidence of relapse', 'timeFrame': 'at 2 years after transplant'}, {'measure': 'non-relapsed mortality', 'timeFrame': 'at 2 years after transplant'}, {'measure': 'GvHD', 'timeFrame': 'at 2 years after transplant', 'description': 'Number of participants who have GvHD symptom'}, {'measure': 'Averse events', 'timeFrame': 'at 2 years after transplant', 'description': 'Averse events of GVHD prophylaxis medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CMV infection', 'CMV reactivation', 'allogenic HSCT', 'GVHD prophylaxis', 'posttransplant cyclophosphamide (PTCy)', 'cyclosporin A', 'methotrexate'], 'conditions': ['CMV Infection or Reactivation After Allogenic HSCT']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:\n\n* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?\n* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT\n* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM\n* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 15 years\n* Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), myelofibrosis primary and/or post PV/ET myelofibrosis, aplastic anemia, lymphoma, or paroxysmal nocturnal hemoglobinuria\n* Received HLA-matched related (MSD-HSCT) or unrelated allo-SCT (MUD-HSCT) or haploidentical hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* Insufficient data needed for analysis'}, 'identificationModule': {'nctId': 'NCT06362720', 'acronym': 'CMV', 'briefTitle': 'The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen', 'orgStudyIdInfo': {'id': '720/2566(IRB2)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standard GVHD prophylaxis', 'description': 'calcineurin inhibitor (cyclosporin A ;CSA) and methotrexate (MTX)'}, {'label': 'posttransplant cyclophosphamide (PTCy)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chutima Kunacheewa, MD', 'role': 'CONTACT', 'email': 'chutima.kua@mahidol.ac.th', 'phone': '+6624197000'}, {'name': 'Weerapat Owatthanapanich, MD', 'role': 'CONTACT', 'email': 'weerapat.owa@mahidol.ac.th', 'phone': '+6624197000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Need a consensus from colleagues'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Chutima Kunacheewa', 'investigatorAffiliation': 'Siriraj Hospital'}}}}