Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT02080195
Status:
TERMINATED
Last Update Posted:
2019-10-02
First Post:
2014-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fbolano2@jhmi.edu', 'phone': '410-614-6398', 'title': 'Javier Bolaños Meade, MD', 'organization': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed weekly through at least Day 60.', 'description': 'Reportable serious adverse events per protocol include: any mortality within the first 100 days after bone marrow transplant (BMT), any graft failures (defined as \\<5% donor chimerism) associated with failure of neutrophil recovery to \\>500/mm³ by day \\~60 after transplantation, and all unexpected events as deemed significant by the PIs. Other events were neither tracked nor reported for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants who were alive at 1 year after transplant and who had not suffered graft rejection, acute or chronic GVHD, or Grade 3 or higher (CTCAE V4.0) adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RIFLE Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'timeFrame': '1 year', 'description': 'Change in Responder Index for Systemic Lupus Erythematosis (RIFLE) assessment. This is a qualitative assessment of organ function. The 12 month response will be assessed as:\n\ncomplete= complete or partial resolution in more than one organ, partial= complete or partial resolution in at least one organ, the same= no change or no worsening in any organ, worse= worsening in any organ', 'reportingStatus': 'POSTED', 'populationDescription': 'The only enrolled participant on this study was never assessed for a follow-up RIFLE scale, so no data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'classes': [{'title': 'Overall Survival', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Event Free Survival', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of patients alive and alive without relapse, respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Graft Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'classes': [{'title': 'Primary graft failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Secondary graft failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Number of participants with primary and/or secondary graft failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Graft Versus Host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'classes': [{'title': 'Grades II-IV acute GVHD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grades III-IV acute GVHD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Chronic Graft Versus Host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who developed chronic GVHD as defined by the NIH consensus criteria. This system gives scores from 0 to 3 for Karnofsky performance score, skin, mouth, eyes, gastrointestinal, liver, lungs, joints, and genitals, as well as an overall severity (mild, moderate, or severe).\n\nMild chronic GVHD involves only 1 or 2 organs or sites (except the lung), with no clinically significant functional impairment (maximum of score 1 in all affected organs or sites).\n\nModerate chronic GVHD involves 1) at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) OR 2) 3 or more organs or sites with no clinically significant functional impairment (maximum score of 1 in all affected organs or sites).\n\nSevere chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients\n\nCyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors\n\nSodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent\n\nFludarabine monophosphate: Purine antimetabolite\n\nTacrolimus: Calcineurin inhibitor\n\nMofetil: Immunosuppressant\n\nRabbit antithymocyte globulin: Selective immunosuppressant'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '1', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-07', 'size': 1075221, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-06T16:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study was unable to accrue subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2014-02-28', 'resultsFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-06', 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching', 'timeFrame': '1 year', 'description': 'Number of participants who were alive at 1 year after transplant and who had not suffered graft rejection, acute or chronic GVHD, or Grade 3 or higher (CTCAE V4.0) adverse events.'}], 'secondaryOutcomes': [{'measure': 'RIFLE Score', 'timeFrame': '1 year', 'description': 'Change in Responder Index for Systemic Lupus Erythematosis (RIFLE) assessment. This is a qualitative assessment of organ function. The 12 month response will be assessed as:\n\ncomplete= complete or partial resolution in more than one organ, partial= complete or partial resolution in at least one organ, the same= no change or no worsening in any organ, worse= worsening in any organ'}, {'measure': 'Survival', 'timeFrame': '1 year', 'description': 'Number of patients alive and alive without relapse, respectively.'}, {'measure': 'Graft Failure', 'timeFrame': '60 days', 'description': 'Number of participants with primary and/or secondary graft failure.'}, {'measure': 'Acute Graft Versus Host Disease (GVHD)', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).'}, {'measure': 'Chronic Graft Versus Host Disease (GVHD)', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants who developed chronic GVHD as defined by the NIH consensus criteria. This system gives scores from 0 to 3 for Karnofsky performance score, skin, mouth, eyes, gastrointestinal, liver, lungs, joints, and genitals, as well as an overall severity (mild, moderate, or severe).\n\nMild chronic GVHD involves only 1 or 2 organs or sites (except the lung), with no clinically significant functional impairment (maximum of score 1 in all affected organs or sites).\n\nModerate chronic GVHD involves 1) at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) OR 2) 3 or more organs or sites with no clinically significant functional impairment (maximum score of 1 in all affected organs or sites).\n\nSevere chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lupus Erythematosus', 'Graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': 'The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.', 'detailedDescription': 'Systemic lupus erythematosus (SLE) is a devastating systemic autoimmune disease that predominantly affects young women, is more common in African-Americans than in whites, and results in poor quality of life. Lupus has no cure, and up to 90% of patients require corticosteroids for disease control. More than half of patients with lupus have permanent organ damage, much of which is either directly due to or increased by corticosteroids. To satisfactorily manage moderate-to-severe SLE, the investigators need effective treatments that will allow corticosteroid-sparing.\n\nHigh-dose chemotherapy followed by autologous BMT or peripheral blood progenitor transplantation (PBSCT) has been proposed as a novel approach to treat severe autoimmune diseases. Allogeneic BMT is not currently utilized for the routine treatment of SLE because of the significant morbidity (GVHD) and mortality associated with the procedure.\n\nThe investigators have recently developed an approach to BMT using post-transplant cyclophosphamide that allows us to safely perform allogeneic BMT from matched, mismatched, unrelated or haploidentical donors. Transplant-related mortality, graft-failure and risk of GVHD have been very low with this approach. Furthermore, this approach allows us to greatly expand the donor pool since any patient shares exactly one HLA haplotype with each biological parent or child and half of siblings, an eligible haploidentical donor can be identified rapidly in nearly all cases.\n\nThis trial will employ a fludarabine + cyclophosphamide conditioning along with posttransplantation cyclophosphamide on for patients with refractory SLE. The purpose of this trial is to improve the salvage rate for patients with refractory SLE through a reformatting of the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Four or more American College of Rheumatology (ACR) criteria for the classification of SLE or 4 or more of the SLICE criteria\n* Involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal\n* A lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment\n* Patients should be eligible for transplantation according to the BMT Policy Manual\n\nExclusion Criteria:\n\n* Age less than 18 years and over 75 years\n* Any risk of pregnancy\n* Patients who are preterminal or moribund'}, 'identificationModule': {'nctId': 'NCT02080195', 'briefTitle': 'Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE', 'orgStudyIdInfo': {'id': 'J13134'}, 'secondaryIdInfos': [{'id': 'NA_00082453', 'type': 'OTHER', 'domain': 'Johns Hopkins IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nonmyeloablative Conditioning and BMT', 'description': 'Nonmyeloablative conditioning with rabbit antithymocyte globulin, cyclophosphamide, fludarabine, and total body irradiation. Allogeneic bone marrow transplant on Day 0. Graft versus host disease (GVHD) prophylaxis with cyclophosphamide, mycophenolate mofetil, and tacrolimus.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Tacrolimus', 'Drug: Mycophenolate Mofetil', 'Drug: Rabbit antithymocyte globulin', 'Radiation: Total body irradiation', 'Biological: Allogeneic bone marrow transplant']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan', 'Cy'], 'description': '14.5 mg/kg/day on Days -6 and -5. 50 mg/kg/day on Days 3 and 4.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['Fludara'], 'description': '30 mg/m\\^2/day on Days -6 through -2.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['FK-506', 'Prograf'], 'description': 'Starting on Day 5. Dose will be adjusted according to blood levels.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept', 'MMF'], 'description': '15 mg/kg three times per day from Day 5 to Day 35.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Rabbit antithymocyte globulin', 'type': 'DRUG', 'otherNames': ['Thymoglobulin'], 'description': '0.5 mg/kg on Day -9. 2 mg/kg/day on Days -8 and -7.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Total body irradiation', 'type': 'RADIATION', 'description': '200 centigray on Day -1.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}, {'name': 'Allogeneic bone marrow transplant', 'type': 'BIOLOGICAL', 'otherNames': ['BMT'], 'description': 'Infusion on Day 0.', 'armGroupLabels': ['Nonmyeloablative Conditioning and BMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Javier Bolaños-Meade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maryland Stem Cell Research Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}