Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 8:20 PM
Study NCT ID:
NCT05245032
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biologically Focused Therapy of Treatment-Refractory MDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with successful ex vivo results', 'timeFrame': '30 days', 'description': 'Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing'}, {'measure': 'Proportion of patients with successful treatment decisions', 'timeFrame': '30 days', 'description': 'Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDS'], 'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.', 'detailedDescription': 'This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.\n\nThe primary objective of the study is:\n\n• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days\n\nThe exploratory objectives of the study are:\n\n• To identify biomarkers that explain ex vivo drug sensitivity results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study will be conducted at a single site, namely Stanford's MDS Center.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent;\n* Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with \\>= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification\n* Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy\n* Cytogenetics reported\n\nExclusion Criteria:\n\n* Hypoplastic MDS\n* Patients without adequate marrow samples for ex vivo analysis'}, 'identificationModule': {'nctId': 'NCT05245032', 'briefTitle': 'Biologically Focused Therapy of Treatment-Refractory MDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Biologically Focused Therapy of Treatment Refractory MDS Patients', 'orgStudyIdInfo': {'id': 'IRB-45236'}, 'secondaryIdInfos': [{'id': 'HEMMDS0035', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': 'IRB-45236', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Feasibility testing', 'description': "During the screening visit, blood and/or a bone marrow sample will be obtained for the patient's standard clinical evaluation. An aliquot of the blood and/or marrow sample will be obtained for ex vivo drug sensitivity assay"}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford MDS Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Peter L Greerberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Universiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Notable Labs Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}