Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-13 @ 9:05 AM
Study NCT ID:
NCT01903928
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests', 'timeFrame': 'for 365 days after HCT'}], 'secondaryOutcomes': [{'measure': 'Local reactogenicity', 'timeFrame': 'for 14 days following each injection', 'description': 'protocol-specified reactogenicity scale'}, {'measure': 'Incidence of CMV viremia', 'timeFrame': 'for 365 days after HCT', 'description': 'CMV plasma viral load ≥ 1000 copies'}, {'measure': 'CMV-specified antiviral therapy', 'timeFrame': 'for 365 days after HCT', 'description': 'CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load ≥ 1000 copies'}, {'measure': 'Incidence of cytomegalovirus end-organ disease (CMV EOD)', 'timeFrame': 'for 365 days after HCT', 'description': 'CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al'}, {'measure': 'Maximum grade of Graft Versus Host Disease (GVHD)', 'timeFrame': 'for 365 days after HCT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cytomegalovirus', 'HCT', 'DNA vaccine', 'transplantation'], 'conditions': ['Allogeneic Hematopoietic Cell Transplant']}, 'referencesModule': {'references': [{'pmid': '27796740', 'type': 'DERIVED', 'citation': 'Mori T, Kanda Y, Takenaka K, Okamoto S, Kato J, Kanda J, Yoshimoto G, Gondo H, Doi S, Inaba M, Kodera Y. Safety of ASP0113, a cytomegalovirus DNA vaccine, in recipients undergoing allogeneic hematopoietic cell transplantation: an open-label phase 2 trial. Int J Hematol. 2017 Feb;105(2):206-212. doi: 10.1007/s12185-016-2110-3. Epub 2016 Oct 28.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=285', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is planned to undergo either of the following:\n\n * Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.\n * Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.\n* Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)\n* Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders\n\nExclusion Criteria:\n\n* Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant\n* Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins\n* Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score \\> 3\n* Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)\n* Subject has received any of the following substances or treatments:\n\n * T-cell depletion of donor cell product.\n * Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.\n * Administration of a CMV vaccine, including any prior exposure to ASP0113.\n* Subject has received an allogeneic stem cell transplant within one year prior to transplant\n* Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy\n* Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.'}, 'identificationModule': {'nctId': 'NCT01903928', 'briefTitle': 'A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)', 'orgStudyIdInfo': {'id': '0113-CL-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP0113 group', 'description': 'Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days -14 to -3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0)', 'interventionNames': ['Biological: ASP0113']}], 'interventions': [{'name': 'ASP0113', 'type': 'BIOLOGICAL', 'description': 'injection', 'armGroupLabels': ['ASP0113 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}