Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT03550703
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label Immunotherapy of Myoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D005350', 'term': 'Fibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label, single arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2018-05-26', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tumor size compared to baseline', 'timeFrame': 'Once monthly for three months', 'description': 'This parameter will be evaluated by pelvic examination and transvaginal ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Changes in bleeding pattern at and between menstruations', 'timeFrame': 'During and between periods for three months', 'description': 'Self-evaluated by patient'}, {'measure': 'Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any', 'timeFrame': '3 months', 'description': 'Self evaluated by patient'}, {'measure': 'Changes in frequent urination or difficulty in emptying the bladder or constipation', 'timeFrame': '3 months', 'description': 'Self evaluated by patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myoma;Uterus', 'Fibroid Uterus', 'Leiomyoma', 'Fibroma']}, 'descriptionModule': {'briefSummary': 'Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.', 'detailedDescription': 'Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Myoma is a female health problem', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -\n\nExclusion Criteria:\n\nother gynecological diseases not related to myoma hysterectomy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03550703', 'acronym': 'V3-myoma', 'briefTitle': 'Open Label Immunotherapy of Myoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunitor LLC'}, 'officialTitle': 'Open Label Phase II Clinical Trial of Myoma Immunotherapy', 'orgStudyIdInfo': {'id': 'Myoma01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm receiving V3-Myoma', 'description': 'A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues', 'interventionNames': ['Biological: V3-Myoma']}], 'interventions': [{'name': 'V3-Myoma', 'type': 'BIOLOGICAL', 'description': 'Once daily oral pill of V3-Myoma', 'armGroupLabels': ['Single arm receiving V3-Myoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'status': 'RECRUITING', 'country': 'Mongolia', 'contacts': [{'name': 'Aldar Bourinbaiar, MD', 'role': 'CONTACT', 'email': 'aldar@immunitor.com', 'phone': '97695130306'}, {'name': 'Marina Tarakanovskaya, MD', 'role': 'CONTACT', 'email': 'marinatarakanovskaya@yahoo.com'}, {'name': 'Galyna Kutsyna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Immunitor LLC', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'centralContacts': [{'name': 'Galyna Kutsyna, MD, MD/PhD', 'role': 'CONTACT', 'email': 'kutsynagalyna@yahoo.com', 'phone': '+97695130306'}, {'name': 'Marina Tarakanovskaya, MD', 'role': 'CONTACT', 'email': 'info@immunitor.com', 'phone': '+97695130306'}], 'overallOfficials': [{'name': 'Aldar Bourinbaiar, PhD, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Immunitor LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Upon study completion the data will be available in peer-reviewed publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunitor LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}