Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04747002
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival', 'timeFrame': '2 year'}], 'secondaryOutcomes': [{'measure': 'Hematological relapse-free survival', 'timeFrame': '2 year'}, {'measure': 'Overall survival', 'timeFrame': '2 year'}, {'measure': 'Adverse event', 'timeFrame': '2 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia in Remission']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/AM05.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.', 'detailedDescription': 'This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification\n2. favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification\n3. 1st hematological after chemotherapy\n4. Human Leukocyte Antigen (HLA)-A\\*02:01, 02:06, 24:02\n5. 20-80 years old\n6. Eastern Cooperative Oncology Group (ECOG) performance Status 0-2\n7. within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively\n8. sufficient organ function as below within 7 days\n\n(1) Neutrophil : \\>= 1000 (2) Cr : \\>= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4) Percutaneous oxygen saturation (SpO2): \\>= 95% 9) patients who agree contraception until 6 months after the last injection 10) non-candidate for hematopoietic stem cell transplantation.\n\n1. illegible for hematopoietic stem cell transplantation (HSCT)\n2. lack of appropriate donor\n3. patients who don't select HSCT at the 1st hematological complete remission (hCR) timing\n\nExclusion Criteria:\n\n1. multiple primary cancer\n2. autoimmune disease\n3. usage of investigational or unapproved drug within 28 days\n4. severe organ failure\n5. Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive\n6. pregnant woman\n7. lactating woman\n8. under treatment against active infection\n9. difficult to enroll because of mental problem\n10. other reasons which investigator judge appropriate for enrollment"}, 'identificationModule': {'nctId': 'NCT04747002', 'briefTitle': 'Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': 'Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.', 'orgStudyIdInfo': {'id': 'WT1-AM-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Administration Group', 'description': 'Patients who are injected with DSP-7888.', 'interventionNames': ['Drug: DSP-7888']}, {'type': 'NO_INTERVENTION', 'label': 'Non-administration Group', 'description': 'Patients who are only under observation.'}], 'interventions': [{'name': 'DSP-7888', 'type': 'DRUG', 'description': 'Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides', 'armGroupLabels': ['Administration Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Jun Nakata', 'role': 'CONTACT', 'email': 'mogura@sahs.med.osaka-u.ac.jp', 'phone': '+81668793676'}], 'facility': 'Osaka University', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Jun Nakata, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'mogura@sahs.med.osaka-u.ac.jp', 'phone': '+81668793676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Japan Agency for Medical Research and Development', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yoichi Yamamoto', 'investigatorAffiliation': 'Osaka University'}}}}