Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-26 @ 12:12 AM
Study NCT ID:
NCT03480360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], '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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': '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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kenneth.R.Meehan@hitchcock.org', 'phone': '(603) 650-4628', 'title': 'Kenneth Meehan, MD', 'organization': 'Dartmouth-Hitchcock Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Monitoring of all acute toxicities (grade 3 or higher) occurred until the time of discharge (post-transplant). After discharge, until day 100, only serious toxicities (grade 4 or higher) were recorded. All-Cause Mortality was monitored from the time of transplant to three years post-transplant.', 'eventGroups': [{'id': 'EG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 5, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Rigors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Dysrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'C. Diff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Central Line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}], 'seriousEvents': [{'term': 'Edema Limbs', 'notes': 'Probably related to pseudo-gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'GI GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Liver GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Skin GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Survived to 100-Days Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post date of peripheral blood transplant', 'description': 'Define 100-day survival of subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Survived to One Year Post-Transplant.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year post date of peripheral blood transplant', 'description': 'Define one year survival of subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Successful Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define number of subjects who experience a successful engraftment: Defined as absolute neutrophil count \\> 500/mm3 and platelets \\> 20,000/mcl for three consecutive days (count first day as engraftment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved a Response to Treatment at 100 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post-peripheral blood transplant', 'description': 'Define response to treatment at 100 days post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved a Response to Treatment at One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year post-peripheral blood transplant', 'description': 'Define response to treatment at one year post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who experienced toxicities associated with this treatment regimen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Incidence of Acute GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who had incidence of acute GVHD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Incidence of Chronic GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who had incidence of chronic GVHD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 30, 60, and 90 post-peripheral blood transplant', 'description': 'Define subjects who experience donor-recipient chimerism following transplant at days 30, 60 and 90. All patients were assessed for donor-recipient chimerism at days 30, 60, and 90, but only one patient experienced chimerism. Day 90 for this patient is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post-peripheral blood transplant', 'description': 'Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immune Checkpoint Regulators - Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'To characterize the incidence of immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation, cytotoxic T-lymphocyte-associated protein 4 \\[CTLA\\], Programmed cell death protein 1 \\[PD-1\\]) during early immune recovery following an allogeneic stem cell transplant.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the checkpoint regulator expression on MDSCs', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the peripheral blood mononuclear cells and myeloid subsets.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the myeloid subsets.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'MDSCs After GVHD Diagnosis - Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the MDSCs frequency.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Checkpoint Regulators - Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Checkpoint Regulators - Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'Flow cytometry will be used to characterize the function of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '21 individuals signed consent. 1 individual was deemed ineligible during screening. Therefore 20 individuals were evaluated for the primary endpoint.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': "Johns Hopkins' Conditioning Regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant\n\nCyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)\n\nFludarabine: 30 mg/m2 daily for 5 days\n\nTotal Body Irradiation: 200 centigray (cGy) for one day (day -1)\n\nTacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.\n\ncellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.\n\ng-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.\n\nPeripheral Blood Transplant: cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.55', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', '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': '20', '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': '20', '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': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Evaluable Participants', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 297430, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-09T11:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2018-01-08', 'resultsFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-28', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Survived to 100-Days Post-transplant', 'timeFrame': '100 days post date of peripheral blood transplant', 'description': 'Define 100-day survival of subjects'}, {'measure': 'Number of Participants Who Survived to One Year Post-Transplant.', 'timeFrame': 'One year post date of peripheral blood transplant', 'description': 'Define one year survival of subjects'}, {'measure': 'Number of Participants Who Experienced a Successful Engraftment', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define number of subjects who experience a successful engraftment: Defined as absolute neutrophil count \\> 500/mm3 and platelets \\> 20,000/mcl for three consecutive days (count first day as engraftment)'}, {'measure': 'Number of Participants Who Achieved a Response to Treatment at 100 Days', 'timeFrame': '100 days post-peripheral blood transplant', 'description': 'Define response to treatment at 100 days post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.'}, {'measure': 'Number of Participants Who Achieved a Response to Treatment at One Year', 'timeFrame': 'One year post-peripheral blood transplant', 'description': 'Define response to treatment at one year post-peripheral blood transplant. The Standard International Criteria for responses for each disease will be used, based on CIBMTR (Center for International Blood and Marrow Transplant Research) criteria.'}, {'measure': 'Number of Participants Who Experienced Toxicities Associated With This Treatment Regimen', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who experienced toxicities associated with this treatment regimen'}, {'measure': 'Number of Participants Who Had Incidence of Acute GVHD', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who had incidence of acute GVHD'}, {'measure': 'Number of Participants Who Had Incidence of Chronic GVHD', 'timeFrame': 'Post-peripheral blood transplant', 'description': 'Define subjects who had incidence of chronic GVHD'}, {'measure': 'Number of Participants Who Experienced Donor-Recipient Chimerism Following Transplant at Days 30, 60, and 90.', 'timeFrame': 'Days 30, 60, and 90 post-peripheral blood transplant', 'description': 'Define subjects who experience donor-recipient chimerism following transplant at days 30, 60 and 90. All patients were assessed for donor-recipient chimerism at days 30, 60, and 90, but only one patient experienced chimerism. Day 90 for this patient is reported.'}, {'measure': 'Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days', 'timeFrame': '100 days post-peripheral blood transplant', 'description': 'Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant'}], 'secondaryOutcomes': [{'measure': 'Immune Checkpoint Regulators - Incidence', 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'To characterize the incidence of immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation, cytotoxic T-lymphocyte-associated protein 4 \\[CTLA\\], Programmed cell death protein 1 \\[PD-1\\]) during early immune recovery following an allogeneic stem cell transplant.'}, {'measure': 'Myeloid-derived Suppressor Cells (MDSCs) After Graft vs. Host Disease (GVHD) Diagnosis - Checkpoint Regulator Expression', 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the checkpoint regulator expression on MDSCs'}, {'measure': 'MDSCs After GVHD Diagnosis - Peripheral Blood Mononuclear Cells', 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the peripheral blood mononuclear cells and myeloid subsets.'}, {'measure': 'MDSCs After GVHD Diagnosis - Myeloid Subsets Using Flow Cytometry', 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the myeloid subsets.'}, {'measure': 'MDSCs After GVHD Diagnosis - Frequency', 'timeFrame': 'Post-transplant through study completion or death, assessed up to 3 years post-transplant', 'description': 'In those patients experiencing GVHD, the study team will define the MDSCs frequency.'}, {'measure': 'Immune Checkpoint Regulators - Prevalence', 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.'}, {'measure': 'Immune Checkpoint Regulators - Function', 'timeFrame': 'Days 30, 60, and 90 post-transplant', 'description': 'Flow cytometry will be used to characterize the function of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haploidentical', 'transplant', 'peripheral blood', 'allogeneic'], 'conditions': ['Acute Myeloid Leukemia', 'Chronic Lymphocytic Leukemia', 'Chronic Myeloid Leukemia', 'Myelodysplasia', 'Myeloproliferative Disorder', 'Myelofibrosis', 'Lymphoma', 'Lymphoma, Non-Hodgkin', 'Plasma Cell Disorder']}, 'referencesModule': {'references': [{'pmid': '23423745', 'type': 'BACKGROUND', 'citation': 'Bashey A, Zhang X, Sizemore CA, Manion K, Brown S, Holland HK, Morris LE, Solomon SR. T-cell-replete HLA-haploidentical hematopoietic transplantation for hematologic malignancies using post-transplantation cyclophosphamide results in outcomes equivalent to those of contemporaneous HLA-matched related and unrelated donor transplantation. J Clin Oncol. 2013 Apr 1;31(10):1310-6. doi: 10.1200/JCO.2012.44.3523. Epub 2013 Feb 19.'}, {'pmid': '22863841', 'type': 'BACKGROUND', 'citation': 'Solomon SR, Sizemore CA, Sanacore M, Zhang X, Brown S, Holland HK, Morris LE, Bashey A. Haploidentical transplantation using T cell replete peripheral blood stem cells and myeloablative conditioning in patients with high-risk hematologic malignancies who lack conventional donors is well tolerated and produces excellent relapse-free survival: results of a prospective phase II trial. Biol Blood Marrow Transplant. 2012 Dec;18(12):1859-66. doi: 10.1016/j.bbmt.2012.06.019. Epub 2012 Aug 1.'}, {'pmid': '26130705', 'type': 'BACKGROUND', 'citation': "Ciurea SO, Zhang MJ, Bacigalupo AA, Bashey A, Appelbaum FR, Aljitawi OS, Armand P, Antin JH, Chen J, Devine SM, Fowler DH, Luznik L, Nakamura R, O'Donnell PV, Perales MA, Pingali SR, Porter DL, Riches MR, Ringden OT, Rocha V, Vij R, Weisdorf DJ, Champlin RE, Horowitz MM, Fuchs EJ, Eapen M. Haploidentical transplant with posttransplant cyclophosphamide vs matched unrelated donor transplant for acute myeloid leukemia. Blood. 2015 Aug 20;126(8):1033-40. doi: 10.1182/blood-2015-04-639831. Epub 2015 Jun 30."}, {'pmid': '18489989', 'type': 'BACKGROUND', 'citation': "Luznik L, O'Donnell PV, Symons HJ, Chen AR, Leffell MS, Zahurak M, Gooley TA, Piantadosi S, Kaup M, Ambinder RF, Huff CA, Matsui W, Bolanos-Meade J, Borrello I, Powell JD, Harrington E, Warnock S, Flowers M, Brodsky RA, Sandmaier BM, Storb RF, Jones RJ, Fuchs EJ. HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2008 Jun;14(6):641-50. doi: 10.1016/j.bbmt.2008.03.005."}, {'pmid': '12663454', 'type': 'BACKGROUND', 'citation': 'Mielcarek M, Martin PJ, Leisenring W, Flowers ME, Maloney DG, Sandmaier BM, Maris MB, Storb R. Graft-versus-host disease after nonmyeloablative versus conventional hematopoietic stem cell transplantation. Blood. 2003 Jul 15;102(2):756-62. doi: 10.1182/blood-2002-08-2628. Epub 2003 Mar 27.'}, {'pmid': '17580263', 'type': 'BACKGROUND', 'citation': 'Giralt S, Logan B, Rizzo D, Zhang MJ, Ballen K, Emmanouilides C, Nath R, Parker P, Porter D, Sandmaier B, Waller EK, Barker J, Pavletic S, Weisdorf D. Reduced-intensity conditioning for unrelated donor progenitor cell transplantation: long-term follow-up of the first 285 reported to the national marrow donor program. Biol Blood Marrow Transplant. 2007 Jul;13(7):844-52. doi: 10.1016/j.bbmt.2007.03.011. Epub 2007 May 24.'}, {'pmid': '24914138', 'type': 'BACKGROUND', 'citation': 'Kekre N, Antin JH. Hematopoietic stem cell transplantation donor sources in the 21st century: choosing the ideal donor when a perfect match does not exist. Blood. 2014 Jul 17;124(3):334-43. doi: 10.1182/blood-2014-02-514760. Epub 2014 Jun 9.'}, {'pmid': '21835146', 'type': 'BACKGROUND', 'citation': 'Bayraktar UD, Champlin RE, Ciurea SO. Progress in haploidentical stem cell transplantation. Biol Blood Marrow Transplant. 2012 Mar;18(3):372-80. doi: 10.1016/j.bbmt.2011.08.001. Epub 2011 Aug 9.'}, {'pmid': '27313619', 'type': 'BACKGROUND', 'citation': 'Parmesar K, Raj K. Haploidentical Stem Cell Transplantation in Adult Haematological Malignancies. Adv Hematol. 2016;2016:3905907. doi: 10.1155/2016/3905907. Epub 2016 May 30.'}, {'pmid': '11939602', 'type': 'BACKGROUND', 'citation': 'Luznik L, Engstrom LW, Iannone R, Fuchs EJ. Posttransplantation cyclophosphamide facilitates engraftment of major histocompatibility complex-identical allogeneic marrow in mice conditioned with low-dose total body irradiation. Biol Blood Marrow Transplant. 2002;8(3):131-8. doi: 10.1053/bbmt.2002.v8.pm11939602.'}, {'pmid': '22796535', 'type': 'BACKGROUND', 'citation': 'Ciurea SO, Mulanovich V, Saliba RM, Bayraktar UD, Jiang Y, Bassett R, Wang SA, Konopleva M, Fernandez-Vina M, Montes N, Bosque D, Chen J, Rondon G, Alatrash G, Alousi A, Bashir Q, Korbling M, Qazilbash M, Parmar S, Shpall E, Nieto Y, Hosing C, Kebriaei P, Khouri I, Popat U, de Lima M, Champlin RE. Improved early outcomes using a T cell replete graft compared with T cell depleted haploidentical hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Dec;18(12):1835-44. doi: 10.1016/j.bbmt.2012.07.003. Epub 2012 Jul 11.'}, {'pmid': '24315844', 'type': 'BACKGROUND', 'citation': 'Chang YJ, Zhao XY, Huang XJ. Immune reconstitution after haploidentical hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Apr;20(4):440-9. doi: 10.1016/j.bbmt.2013.11.028. Epub 2013 Dec 4.'}, {'pmid': '17924994', 'type': 'BACKGROUND', 'citation': 'Habicht A, Kewalaramani R, Vu MD, Demirci G, Blazar BR, Sayegh MH, Li XC. Striking dichotomy of PD-L1 and PD-L2 pathways in regulating alloreactive CD4(+) and CD8(+) T cells in vivo. Am J Transplant. 2007 Dec;7(12):2683-92. doi: 10.1111/j.1600-6143.2007.01999.x. Epub 2007 Oct 9.'}, {'pmid': '17667813', 'type': 'BACKGROUND', 'citation': 'Schilbach K, Schick J, Wehrmann M, Wollny G, Simon P, Schlegel PG, Eyrich M. PD-1-PD-L1 pathway is involved in suppressing alloreactivity of heart infiltrating t cells during murine gvhd across minor histocompatibility antigen barriers. 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The role of programmed cell death ligand-1 (PD-L1/CD274) in the development of graft versus host disease. PLoS One. 2013 Apr 4;8(4):e60367. doi: 10.1371/journal.pone.0060367. Print 2013.'}, {'pmid': '24691994', 'type': 'BACKGROUND', 'citation': 'Le Mercier I, Chen W, Lines JL, Day M, Li J, Sergent P, Noelle RJ, Wang L. VISTA Regulates the Development of Protective Antitumor Immunity. Cancer Res. 2014 Apr 1;74(7):1933-44. doi: 10.1158/0008-5472.CAN-13-1506.'}, {'pmid': '24894088', 'type': 'BACKGROUND', 'citation': 'Lines JL, Sempere LF, Broughton T, Wang L, Noelle R. VISTA is a novel broad-spectrum negative checkpoint regulator for cancer immunotherapy. Cancer Immunol Res. 2014 Jun;2(6):510-7. doi: 10.1158/2326-6066.CIR-14-0072.'}, {'pmid': '25964334', 'type': 'BACKGROUND', 'citation': 'Liu J, Yuan Y, Chen W, Putra J, Suriawinata AA, Schenk AD, Miller HE, Guleria I, Barth RJ, Huang YH, Wang L. Immune-checkpoint proteins VISTA and PD-1 nonredundantly regulate murine T-cell responses. Proc Natl Acad Sci U S A. 2015 May 26;112(21):6682-7. doi: 10.1073/pnas.1420370112. Epub 2015 May 11.'}, {'pmid': '20807889', 'type': 'BACKGROUND', 'citation': 'Highfill SL, Rodriguez PC, Zhou Q, Goetz CA, Koehn BH, Veenstra R, Taylor PA, Panoskaltsis-Mortari A, Serody JS, Munn DH, Tolar J, Ochoa AC, Blazar BR. Bone marrow myeloid-derived suppressor cells (MDSCs) inhibit graft-versus-host disease (GVHD) via an arginase-1-dependent mechanism that is up-regulated by interleukin-13. Blood. 2010 Dec 16;116(25):5738-47. doi: 10.1182/blood-2010-06-287839. Epub 2010 Aug 31.'}, {'pmid': '26185131', 'type': 'BACKGROUND', 'citation': 'Messmann JJ, Reisser T, Leithauser F, Lutz MB, Debatin KM, Strauss G. In vitro-generated MDSCs prevent murine GVHD by inducing type 2 T cells without disabling antitumor cytotoxicity. Blood. 2015 Aug 27;126(9):1138-48. doi: 10.1182/blood-2015-01-624163. Epub 2015 Jul 16.'}, {'pmid': '24464140', 'type': 'BACKGROUND', 'citation': 'Rieber N, Wecker I, Neri D, Fuchs K, Schafer I, Brand A, Pfeiffer M, Lang P, Bethge W, Amon O, Handgretinger R, Hartl D. Extracorporeal photopheresis increases neutrophilic myeloid-derived suppressor cells in patients with GvHD. Bone Marrow Transplant. 2014 Apr;49(4):545-52. doi: 10.1038/bmt.2013.236. Epub 2014 Jan 27.'}]}, 'descriptionModule': {'briefSummary': "The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.", 'detailedDescription': "We propose a clinical trial to define clinical endpoints, including engraftment, 100-day survival and one year survival (Objective #1). We will characterize the incidence, prevalence and function of immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). We will correlate these laboratory results with clinical outcomes and the incidence of GVHD. As an exploratory aim, in those patients experiencing GVHD and requiring treatment, we will define the frequency/expression of checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: less than 75 years\n* The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP - Pre-transplant Evaluation of allogeneic recipient (Appendix).\n* The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:\n* Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia\n* Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia\n* Myelodysplasia\n* Myeloproliferative disorder\n* Myelofibrosis\n* Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease\n* Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia\n* Donor availability- the patient must have an identified RELATED haplo-identical donor\n* No Human Immunodeficiency Virus infection or active hepatitis B or C\n* Eastern Cooperative Oncology Group performance status: 0-2\n* Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted\n* Left ventricular ejection fraction greater than or equal to 40%\n* Serum bilirubin \\< 2x upper limit of normal; transaminases \\< 3x normal at the time of transplant\n* No active or uncontrollable infection\n* In female, a negative pregnancy test if experiencing menstrual periods\n* No major organ dysfunction precluding transplantation\n* No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision).\n\nExclusion Criteria:\n\n* Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.\n* Major anticipated illness or organ failure incompatible with survival from bone marrow transplant.\n* History of refractory systemic infection\n\nDONOR ELIGIBILITY\n\n* Human leukocyte antigen (HLA) haplo-identical matched related.\n* The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix)\n* The donor must have no significant co-morbidities that would put the donor at marked increased risk\n* There is no age restriction for the donor\n* Informed consent must be signed by donor\n\nDONOR EXCLUSION CRITERIA\n\n* The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible:\n* Pregnant or lactating donor\n* HIV or active Hep B or C in the donor\n* Donor unfit to receive G-CSF and undergo apheresis\n* A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible"}, 'identificationModule': {'nctId': 'NCT03480360', 'briefTitle': "Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression", 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': "Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression", 'orgStudyIdInfo': {'id': 'D17170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Johns Hopkins' conditioning regimen", 'description': 'Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Radiation: Total Body Irradiation', 'Drug: Tacrolimus', 'Drug: cellcept', 'Drug: g-csf', 'Procedure: Peripheral Blood Transplant']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': '30 mg/m2 daily for 5 days', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'Total Body Irradiation', 'type': 'RADIATION', 'description': '200 centigray (cGy) for one day (day -1)', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': '1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'cellcept', 'type': 'DRUG', 'description': 'dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'g-csf', 'type': 'DRUG', 'description': '5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \\> 1000/mcL for 3 days.', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}, {'name': 'Peripheral Blood Transplant', 'type': 'PROCEDURE', 'description': 'cell dose goal: \\< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight', 'armGroupLabels': ["Johns Hopkins' conditioning regimen"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Kenneth Meehan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investogator- Kenneth Meehan, MD Staff Physician', 'investigatorFullName': 'Kenneth Meehan', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}