Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-26 @ 6:26 PM
Study NCT ID:
NCT01969695
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2013-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiac assessment findings', 'timeFrame': 'Measured from Day 1 up to 6 years after the last subject has enrolled in the study', 'description': 'Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram'}, {'measure': 'Percentage of subjects with adverse events', 'timeFrame': 'Measured up to 6 years after the last subject has enrolled in the study', 'description': 'Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study'}, {'measure': 'Change in clinical laboratory test results', 'timeFrame': 'Measured from Day 1 up to 6 years after the last subject has enrolled in the study', 'description': 'Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'Measured up to 6 years after the last subject has enrolled in the study', 'description': 'Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study'}, {'measure': 'Change in physical exam finding, including vital signs', 'timeFrame': 'Measured from Day 1 up to 6 years after the last subject has enrolled in the study', 'description': 'Body temperature, weight, blood pressure, heart rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABT-199', 'Cancer', 'GDC-0199', "non-Hodgkin's lymphoma", 'Relapsed', 'Refractory', 'Safety'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma \\[CLL\\], small lymphocytic lymphoma \\[SLL\\], and mantle cell lymphoma \\[MCL\\]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.\n\nExclusion Criteria:\n\n* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).\n* Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.\n* Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy.\n* Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL)."}, 'identificationModule': {'nctId': 'NCT01969695', 'briefTitle': "An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'M13-835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT-199', 'description': 'ABT-199 monotherapy', 'interventionNames': ['Drug: ABT-199']}], 'interventions': [{'name': 'ABT-199', 'type': 'DRUG', 'otherNames': ['GDC-0199'], 'description': 'ABT-199 continuous once daily dosing', 'armGroupLabels': ['ABT-199']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719-1478', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Arthritis Center /ID# 101359', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Med Ctr /ID# 92596', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Univ Med Ctr /ID# 101417', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}