Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT03337451
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-08-16', 'releaseDate': '2021-07-19'}], 'estimatedResultsFirstSubmitDate': '2021-07-19'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585159', 'term': 'tomaralimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2019-01-24', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2017-10-18', 'dispFirstSubmitQcDate': '2019-01-24', 'studyFirstSubmitQcDate': '2017-11-06', 'dispFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and types of Serious Adverse events', 'timeFrame': 'monthly through study completion, an average of 18 months'}, {'measure': 'monitor ongoing efficacy responses', 'timeFrame': 'monthly through study completion, an average of 18 months', 'description': 'To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of the OPN-305-106 study\n* Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.\n* Provide written informed consent for the follow up protocol.\n\nExclusion Criteria:\n\n* Refusal to provide written informed consent\n* Withdrawal from the OPN-305-106 study prior to the final EOT visit\n* Plan to be included into another interventional investigational study.\n* Progression of disease'}, 'identificationModule': {'nctId': 'NCT03337451', 'briefTitle': 'Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opsona Therapeutics Ltd.'}, 'officialTitle': 'Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'OPN-305-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPN-305', 'interventionNames': ['Drug: OPN-305']}], 'interventions': [{'name': 'OPN-305', 'type': 'DRUG', 'description': 'Patients will receive study drug every 4 weeks', 'armGroupLabels': ['OPN-305']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opsona Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, {'name': 'New York Presbyterian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-07-19', 'type': 'RELEASE'}, {'date': '2021-08-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Opsona Therapeutics Ltd.'}}}}