Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02169505
Status:
TERMINATED
Last Update Posted:
2019-11-27
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079963', 'term': 'Brentuximab Vedotin'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sahmed3@mdanderson.org', 'phone': '713-792-7734', 'title': 'Ahmed,Sairah,MD / Stem Cell Transplantation', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': '1.2 mg/kg for C1-2 then 1.8mg/kg for C3-6', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dcreased WBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Decreased PLT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Secondary Graft Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'An average of 12 months', 'description': 'Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \\<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematologic Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'The most common grade \\> 3 side effects on Brentuximab.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'Evaluate the CMV in blood', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Graft-versus-host Disease (GVHD).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'The tissue and serum in participants were measured by the GVHD', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Central and Effector Cell Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6', 'description': 'Dose will be reduced from 1.8 mg/kg to 1.2 mg/kg or from 1.2 mg/kg to 1 mg/kg or from 1 mg/kg to stop treatment if:\n\n1. Neutropenia grade 3-4 unresponsive to G-CSF or grade 4 thrombocytopenia are observed.\n2. Peripheral neuropathy, new or worsening grade 2 or 3. Withhold treatment until improvement or return to grade 1 or baseline; then resume with a dose reduction.\n\nDose will be reduced to 1 mg/kg if:\n\n1. Creatinine clearance \\< 30 cc/min as defined by MDRD method from NKDEP. http://nkdep.nih.gov/lab-evaluation/gfr/estimating.shtml\n2. Hepatic impairment defined as bilirubin \\> 2 mg/dL.\n\nIf the patient develops grade 3-4 neutropenia unresponsive to G-CSF: Hold until resolution to grade \\</= 1 and restart at lower dose.'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Progression-free survival', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'an average of 12 months', 'description': 'The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant one had a progression free survival and overall survival.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safety and Efficacy of Brentuximab Vedotin Maintenance After A', 'description': 'Study the safety of Brentuximab in patients with HL or ALCL who have had an allo or haplo stem cell transplant. Also learn if drug prevents the disease from coming back.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who have had an Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety and Efficacy of Brentuximab Vedotin Maintenance After A', 'description': 'Study the safety of Brentuximab in patients with HL or ALCL who have had an allo or haplo stem cell transplant. Also learn if drug prevents the disease from coming back.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-03', 'size': 159897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-31T11:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Slow Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2014-06-11', 'resultsFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-24', 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Secondary Graft Failure', 'timeFrame': 'An average of 12 months', 'description': 'Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \\<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Hematologic Toxicity', 'timeFrame': 'an average of 12 months', 'description': 'The most common grade \\> 3 side effects on Brentuximab.'}, {'measure': 'Number of Participants With Relapse', 'timeFrame': 'an average of 12 months', 'description': 'Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.'}, {'measure': 'Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.', 'timeFrame': 'an average of 12 months', 'description': 'Evaluate the CMV in blood'}, {'measure': 'Number of Participants With Acute Graft-versus-host Disease (GVHD).', 'timeFrame': 'an average of 12 months', 'description': 'The tissue and serum in participants were measured by the GVHD'}, {'measure': 'Number of Participants With Central and Effector Cell Effects', 'timeFrame': 'an average of 12 months', 'description': 'We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.'}, {'measure': 'Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration', 'timeFrame': 'an average of 12 months', 'description': 'Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.'}, {'measure': 'Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance', 'timeFrame': 'an average of 12 months', 'description': 'The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Hodgkin lymphoma', 'HL', 'CD30 positive Hodgkin Lymphoma', 'Anaplastic large cell lymphoma', 'ALCL', 'Allogeneic Stem Cell Transplantation', 'ASCT', 'Graft-versus-host disease', 'GVHD', 'Brentuximab Vedotin', 'SGN-35', 'Adcetris'], 'conditions': ['Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.', 'detailedDescription': "Study Drug Administration:\n\nIf you agree to take part in this study, about 35-60 days after the transplant, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of each 21-day study cycle. You may receive up to 6 cycles of brentuximab vedotin.\n\nAt Cycles 3 and beyond, you will receive a higher dose of the study drug than you received during Cycles 1 and 2.\n\nStudy Visits:\n\nAbout 5 days before Day 1 of Cycle 1:\n\n* You will have a physical exam. As part of the physical exam, you will be checked for graft-versus-host disease (GVHD -- when transplanted donor tissue attacks the tissues of the recipient's body). You may have an additional blood draw to check for GVHD as part of your standard of care.\n* Blood (about 2 tablespoons) will be drawn for routine tests and to check how the transplant has taken.\n* Blood (about 2 teaspoons each time) will be drawn before and after your dose of study drug to check the immune system.\n\nOn Days 3 and 5 of Cycle 1, blood (about 2 teaspoons) will be drawn to check the immune system.\n\nAbout 5 days before Day 1 of Cycles 2-6:\n\n* You will have a physical exam.\n* Blood (about 2 tablespoons) will be drawn for routine tests and to check the immune system.\n\nIf your doctor thinks it is needed, you may have a skin biopsy or endoscopy to check for GVHD and/or graft failure. You will sign a separate consent form that explains the procedures and risks.\n\nLength of Study:\n\nYou will be taken off study 1 year after the transplant. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop an infection (such as cytomegalovirus \\[CMV\\] that does not respond to treatment), or if you are unable to follow study directions.\n\nYour participation on the study will be over after the follow-up visits.\n\nFollow-Up Visits:\n\nAbout 1, 3, 6, and 12 months after the transplant, you will have follow-up visits as part of your standard of care after your transplant. At these visits:\n\n* You will have a physical exam\n* Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant has taken, and to check the status of the disease.\n* You will have a computed tomography (CT) scan to check the status of the disease.\n* You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing. To collect a bone marrow biopsy/aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Cytogenetic testing looks at how genetic changes to cells may affect how the disease may react to the study drug.\n\nThis is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of Hodgkin lymphoma and ALCL. It is investigational to give brentuximab vedotin at an earlier time after a transplant.\n\nUp to 20 participants will be enrolled in this study. All will take part at MD Anderson."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only).\n2. Age 18 to 65 years.\n3. Performance status: Zubrod 0-1 or Karnofsky 80-100.\n4. Serum creatinine \\< 1.5 mg/dL or creatinine clearance greater than or equal to 40 cc/min as defined by MDRD method from National Kidney Disease Education Program (NKDEP).\n5. Serum direct bilirubin \\< 1.5 mg/dL (unless Gilbert's syndrome).\n6. SGPT \\< 200 IU/L unless related to patient's malignancy.\n7. Evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater to 1000 without growth factor support for at least 5 days.\n8. Patients with previous exposure to brentuximab pre-transplant are eligible for the study.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.\n2. Presence of steroid-refractory acute graft-versus-host disease (GVHD).\n3. Patients that underwent allogeneic transplantation as a treatment of graft failure.\n4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease."}, 'identificationModule': {'nctId': 'NCT02169505', 'briefTitle': 'Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Safety and Efficacy of Brentuximab Vedotin Maintenance After Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)', 'orgStudyIdInfo': {'id': '2013-0351'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01593', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brentuximab Vedotin', 'description': 'Brentuximab by vein over 30 minutes every 3 weeks for a total of 6 cycles starting between days 30 and 60 post allogeneic stem cell transplant (SCT).\n\nBrentuximab dose based on actual body weight starting with an initial dose of 1.2 mg/kg for the first 2 cycles and dose increased to 1.8 mg/kg after the second cycle for all subsequent cycles.', 'interventionNames': ['Drug: Brentuximab Vedotin']}], 'interventions': [{'name': 'Brentuximab Vedotin', 'type': 'DRUG', 'otherNames': ['SGN-35', 'Adcetris'], 'description': 'Starting dose: 1.2 mg/kg by vein on Day 1 for the first 2, 21 day cycles. Dose increased to 1.8 mg/kg by vein after the second cycle for all subsequent cycles.', 'armGroupLabels': ['Brentuximab Vedotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sairah Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}