Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 9:44 PM
Study NCT ID:
NCT03379051
Status:
TERMINATED
Last Update Posted:
2022-08-22
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-21', 'mcpReleaseN': 46, 'releaseDate': '2023-05-26'}], 'estimatedResultsFirstSubmitDate': '2023-05-26'}}, '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': 'C579720', 'term': 'venetoclax'}, {'id': 'C000626319', 'term': 'umbralisib'}, {'id': 'C000619007', 'term': 'ublituximab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'Strategic/Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine Acceptable Adverse Events That Are Related to Treatment', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Overall Response and Complete Remission Rate', 'timeFrame': '12 months'}, {'measure': 'Minimum Residual Disease (MRD)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Non-Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '37871300', 'type': 'DERIVED', 'citation': 'Hill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693.'}]}, 'descriptionModule': {'briefSummary': 'Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma\n* Refractory to or relapsed after at least 1 prior treatment regimen\n* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2\n\nExclusion Criteria:\n\n* Any major surgery, chemotherapy or immunotherapy within the last 21 days\n* Known hepatitis B virus, hepatitis C virus or HIV infection\n* Known histological transformation from CLL to an aggressive lymphoma (Richter's)"}, 'identificationModule': {'nctId': 'NCT03379051', 'briefTitle': 'Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL', 'orgStudyIdInfo': {'id': 'U2-VEN-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ublituximab + Umbralisib + Venetoclax', 'description': 'Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose', 'interventionNames': ['Drug: Venetoclax', 'Drug: Umbralisib', 'Biological: Ublituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Ublituximab + Umbralisib + Lenalidomide', 'description': 'Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days', 'interventionNames': ['Drug: Umbralisib', 'Biological: Ublituximab', 'Drug: Lenalidomide']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta'], 'description': 'BCL-2 Inhibitor', 'armGroupLabels': ['Ublituximab + Umbralisib + Venetoclax']}, {'name': 'Umbralisib', 'type': 'DRUG', 'otherNames': ['TGR-1202'], 'description': 'PI3K-Delta Inhibitor', 'armGroupLabels': ['Ublituximab + Umbralisib + Lenalidomide', 'Ublituximab + Umbralisib + Venetoclax']}, {'name': 'Ublituximab', 'type': 'BIOLOGICAL', 'otherNames': ['TG-1101'], 'description': 'Glycoengineered Anti-CD20 mAb', 'armGroupLabels': ['Ublituximab + Umbralisib + Lenalidomide', 'Ublituximab + Umbralisib + Venetoclax']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid'], 'description': 'Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties', 'armGroupLabels': ['Ublituximab + Umbralisib + Lenalidomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Paul Barr, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wilmot Cancer Institute - University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TG Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'James P. Wilmot Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}