Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-22 @ 7:20 AM
Study NCT ID:
NCT03207256
Status:
TERMINATED
Last Update Posted:
2022-07-21
First Post:
2017-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-16', 'mcpReleaseN': 41, 'releaseDate': '2023-05-25'}, {'resetDate': '2023-07-28', 'mcpReleaseN': 42, 'releaseDate': '2023-07-11'}], 'estimatedResultsFirstSubmitDate': '2023-05-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626319', 'term': 'umbralisib'}, {'id': 'C000619007', 'term': 'ublituximab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Strategic/Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities', 'timeFrame': 'Evaluated at each planned visit through study completion, an average of 2 years', 'description': 'Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment', 'timeFrame': 'Evaluated at each planned visit through study completion, an average of 2 years', 'description': 'Date of progression reported for each patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.\n* Subjects must have completed at least 6 cycles of therapy on their current protocol.\n\nExclusion Criteria:\n\n* Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.'}, 'identificationModule': {'nctId': 'NCT03207256', 'briefTitle': 'Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.', 'orgStudyIdInfo': {'id': 'UTX-TGR-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TGR-1202', 'description': 'Oral TGR-1202 Daily', 'interventionNames': ['Drug: TGR-1202']}, {'type': 'EXPERIMENTAL', 'label': 'TGR-1202 + Ublituximab', 'description': 'Oral TGR-1202 in combination with Ublituximab intravenous administration', 'interventionNames': ['Drug: TGR-1202 + Ublituximab']}], 'interventions': [{'name': 'TGR-1202', 'type': 'DRUG', 'description': 'Oral Daily TGR-1202', 'armGroupLabels': ['TGR-1202']}, {'name': 'TGR-1202 + Ublituximab', 'type': 'DRUG', 'description': 'Oral Daily TGR-1202 + Ublituximab IV Administration', 'armGroupLabels': ['TGR-1202 + Ublituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United 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'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TG Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}