Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT03593902
Status:
TERMINATED
Last Update Posted:
2020-08-12
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cardiac Safe Transplants for Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015080', 'term': 'Mesna'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'C495669', 'term': 'Octagam'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathleen.quigley@nm.org', 'phone': '312-695-8192', 'title': 'Kathleen Quigley', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination of study due to PI Sabbatical led to small number of participants analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'During Treatment and the First 100 days Post Treatment', 'description': 'Grade 4 Toxicities', 'eventGroups': [{'id': 'EG000', 'title': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.\n\nRituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer\n\nFludarabine: A chemotherapy medication commonly used in the treatment of leukemia \\& lymphoma\n\nCyclophosphamide: A medication used as chemotherapy and to suppress the immune system\n\nMesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder\n\nrATG: A rabbit polyclonal antibody to lymphocytes\n\nMethylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation\n\nG-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Skin Score by mRSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.\n\nRituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer\n\nFludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma\n\nCyclophosphamide: A medication used as chemotherapy and to suppress the immune system\n\nMesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder\n\nrATG: A rabbit polyclonal antibody to lymphocytes\n\nMethylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation\n\nG-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and'}], 'classes': [{'title': 'Pre Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '48'}]}]}, {'title': 'Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre Treatment and Post Treatment', 'description': 'Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in one or more rows differs from the overall number analyzed because some patients did not follow up after the treatment.'}, {'type': 'SECONDARY', 'title': 'Survival of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.\n\nRituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer\n\nFludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma\n\nCyclophosphamide: A medication used as chemotherapy and to suppress the immune system\n\nMesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder\n\nrATG: A rabbit polyclonal antibody to lymphocytes\n\nMethylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation\n\nG-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Treatment and Post Treatment up to 1 year', 'description': 'Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.\n\nRituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer\n\nFludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma\n\nCyclophosphamide: A medication used as chemotherapy and to suppress the immune system\n\nMesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder\n\nrATG: A rabbit polyclonal antibody to lymphocytes\n\nMethylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation\n\nG-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.\n\nRituximab: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer\n\nFludarabine: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma\n\nCyclophosphamide: A medication used as chemotherapy and to suppress the immune system\n\nMesna: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder\n\nrATG: A rabbit polyclonal antibody to lymphocytes\n\nMethylprednisolone: A corticosteroid medication used to suppress the immune system and decrease inflammation\n\nG-CSF: A glycoprotein that stimulates the bone marrow to produce granulocytes and'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', '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': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', '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': 'Modified Rodnan skin score', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'description': 'The modified Rodnan skin score (MRSS) is a measure for skin disease in systemic scleroderma and is calculated by summation of skin thickness in 17 different body sites. The range is 0 (normal skin thickness to 51 (severe thickness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-09', 'size': 15139, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-07T13:12', 'hasProtocol': False}, {'date': '2019-10-09', 'size': 1739959, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-10T17:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'PI Sabbatical', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2018-06-28', 'resultsFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Skin Score by mRSS', 'timeFrame': 'Pre Treatment and Post Treatment', 'description': 'Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51).'}], 'secondaryOutcomes': [{'measure': 'Survival of Treatment', 'timeFrame': 'During Treatment and Post Treatment up to 1 year', 'description': 'Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Stem Cell Transplantation', 'Hematopoietic Stem Cell Transplant'], 'conditions': ['Systemic Sclerosis', 'Scleroderma']}, 'referencesModule': {'references': [{'pmid': '32612255', 'type': 'DERIVED', 'citation': 'Burt RK, Han X, Quigley K, Arnautovic I, Shah SJ, Lee DC, Freed BH, Jovanovic B, Helenowski IB. Cardiac safe hematopoietic stem cell transplantation for systemic sclerosis with poor cardiac function: a pilot safety study that decreases neutropenic interval to 5 days. Bone Marrow Transplant. 2021 Jan;56(1):50-59. doi: 10.1038/s41409-020-0978-2. Epub 2020 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to treat systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.', 'detailedDescription': 'The autologous hematopoietic stem cell transplant used in this research study is an investigational procedure that uses cyclophosphamide and fludarabine (chemotherapy), rabbit anti-thymocyte globulin (rATG) (a protein that kills the immune cells that are thought to be causing your disease), and rituximab (a biologic drug that targets B cells of your immune system). After use of these treatments, the patient will receive their own previously collected blood stem cells (autologous stem cell transplant). The ability of these experimental treatments to stop relapses and progression (worsening) of your systemic sclerosis will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 65 years old at the time of pre-transplant evaluation\n2. An established diagnosis of systemic sclerosis\n3. Diffuse cutaneous systemic sclerosis with involvement proximal to the elbow or knee and a modified Rodnan Skin Score of ≥ 14 (see Appendix A)\n\nAND\n\nAny one of the following:\n\n1. DLCO \\< 80% of predicted or decrease in lung function (DLCO, DLCO/VA or FVC) of 10% or more over 12 months.\n2. Pulmonary fibrosis or alveolitis on CT scan or chest x-ray (ground glass appearance of alveolitis).\n3. Abnormal EKG (non-specific ST-T wave abnormalities, low QRS voltage, or ventricular hypertrophy), or pericardial effusion or pericardial enhancement without constriction on MRI\n4. Gastrointestinal tract involvement confirmed on radiological study. Radiologic findings of scleroderma are small bowel radiographs showing thickened folds with dilated loops, segmentation, and flocculation +/- diverticula, or pseudodiverticula. A hide-bound appearance may be present (e.g. dilated and crowded circular folds). GI involvement may also be confirmed by D-xylose malabsorption, patulous esophagus on high-resolution computed tomography (HRCT), or esophageal manometry.\n\nOR\n\nLimited cutaneous systemic sclerosis (SSc) (modified Rodnan Skin Score \\<14) with lung involvement defined as active alveolitis on bronchoalveolar lavage (BAL), ground-glass opacity on CT scan, a DLCO \\< 80% predicted, or decrease in lung function (DLCO/VA, DLCO, FVC) of 10% or more in last 12 months.\n\nOther Inclusion Criteria for "CAST" Conditioning Regimen (presence of any of the following):\n\n1. Septal flattening or D-sign on MRI (without deep breathing)\n2. PASP \\>40 mm Hg or \\>45 mm Hg with fluid challenge\\*\n3. mPAP \\>25 mm Hg or \\>30 mm Hg with fluid challenge\\*\n4. Non-ischemia diffuse ventricular hypokinesis or non-ischemia wall hypokinesis\n\n * Fluid challenge is 1000 ml normal saline over 10 minutes. Fluid challenge will not be done if right atrial pressure is \\>13 mm Hg at rest or pulmonary capillary wedge pressure is \\>20 mm Hg at rest.\n\nExclusion Criteria:\n\n1. Active ischemic heart disease or untreated coronary artery disease\n2. Untreated life-threatening cardiac arrhythmia on EKG or 24-hour holter\n3. Pericardial effusion \\> 1 cm on cardiac MRI unless successful pericardiocentesis has been performed\n4. LVEF \\<35%\n5. End-stage lung disease characterized by TLC\\<45% of predicted value, or DLCO hemoglobin corrected \\< 30 % predicted.\n6. Creatinine clearance \\<40 by 24-hour urine\n7. History of breast implants that have not been removed (unless they cannot be surgically removed due to risks of surgery)\n8. Liver cirrhosis, transaminases \\>2x of normal limits, or bilirubin \\> 2.0 unless due to Gilbert\'s disease\n9. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment\n10. Prior history of malignancy\n11. Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy\n12. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible\n13. Major hematological abnormalities such as platelet count \\< 100,000/ul or absolute neutrophil count (ANC) \\< 1000/ul\n14. HIV positive\n15. Hepatitis B or C positive\n16. PASP \\>50 mmHg without fluid challenge\n17. mPAP \\>34 mmHg without fluid challenge\n18. Coronary artery disease not reversed by cardiology and interventional radiology'}, 'identificationModule': {'nctId': 'NCT03593902', 'acronym': 'CAST', 'briefTitle': 'Cardiac Safe Transplants for Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction', 'orgStudyIdInfo': {'id': 'DIAD.CAST.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hematopoietic Stem Cell Transplantation', 'description': 'Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.', 'interventionNames': ['Drug: Rituximab', 'Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Mesna', 'Drug: rATG', 'Drug: Methylprednisolone', 'Drug: G-CSF', 'Biological: IVIg', 'Biological: Autologous Stem Cells']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan'], 'description': 'Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['Fludara'], 'description': 'A chemotherapy medication commonly used in the treatment of leukemia and lymphoma', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'A medication used as chemotherapy and to suppress the immune system', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'Mesna', 'type': 'DRUG', 'otherNames': ['Mesnex'], 'description': 'A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'rATG', 'type': 'DRUG', 'otherNames': ['Thymoglobulin', 'Anti-Thymocyte Globulin (Rabbit)'], 'description': 'A rabbit polyclonal antibody to lymphocytes', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-Medrol', 'Depo-Medrol'], 'description': 'A corticosteroid medication used to suppress the immune system and decrease inflammation', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['Neupogen', 'Filgrastim', 'Granix', 'Zarxio'], 'description': 'A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'IVIg', 'type': 'BIOLOGICAL', 'otherNames': ['Bivagam', 'Carimune NF', 'Gammagard', 'Privigen', 'Octagam'], 'description': 'Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects', 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}, {'name': 'Autologous Stem Cells', 'type': 'BIOLOGICAL', 'description': "Infusion of patient's own stem cells", 'armGroupLabels': ['Hematopoietic Stem Cell Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University, Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Richard Burt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Burt, MD', 'investigatorAffiliation': 'Northwestern University'}}}}