Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-02-21 @ 9:03 AM
Study NCT ID:
NCT02013128
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ublituximab + Ibrutinib in Select B-cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], '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': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619007', 'term': 'ublituximab'}, {'id': 'C551803', 'term': 'ibrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2022-10-21', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2013-12-11', 'dispFirstSubmitQcDate': '2022-10-21', 'studyFirstSubmitQcDate': '2013-12-16', 'dispFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies', 'timeFrame': '28 days (1 cycle of therapy)', 'description': 'To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'Up to 1 year', 'description': 'To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.\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* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.\n* Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma"}, 'identificationModule': {'nctId': 'NCT02013128', 'briefTitle': 'Ublituximab + Ibrutinib in Select B-cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies', 'orgStudyIdInfo': {'id': 'UTX-IB-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ublituximab + ibrutinib', 'description': 'Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose', 'interventionNames': ['Drug: Ublituximab', 'Drug: Ibrutinib']}], 'interventions': [{'name': 'Ublituximab', 'type': 'DRUG', 'description': 'Ublituximab (IV infusion)', 'armGroupLabels': ['Ublituximab + ibrutinib']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['Ibrutinib (IMBRUVICA)'], 'description': 'Ibrutinib oral daily dose', 'armGroupLabels': ['Ublituximab + ibrutinib']}]}, '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': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 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'lon': -122.67621}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Jeff Sharman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Willamette Valley Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TG Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}