Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT00896493
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2009-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Sponsor:
Organization:
Raw JSON
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Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 20, 'seriousNumAtRisk': 38, 'deathsNumAffected': 21, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Serum sickness', 'notes': 'Serum sickness from ATG infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disease Relapse', 'notes': 'Relapse of lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary Malignancy', 'notes': 'Localized cutaneous squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'notes': 'Anemia needing transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'notes': 'Neutrophil \\<0.5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'Platelet count \\<10,000', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection, non-specified', 'notes': 'Central-line related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post transplant lymphoproliferative disorder (PTLD)', 'notes': 'Post-transplant lymphoproliferative disorder (PTLD) secondary to Epstein Barr virus (EBV) reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CMV viremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'EBV viremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Secondary Malignancy', 'notes': 'Acute lymphoblastic leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary Malignancy', 'notes': 'Metastatic cutaneous squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Viral Hepatitis', 'notes': 'Hepatitis B infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver Failure', 'notes': 'Liver failure due to disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Bleeding', 'notes': 'Acute GI GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinemia', 'notes': 'Acute Liver GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-organ failure', 'notes': 'Secondary to acute GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage', 'notes': 'Internal bleeding from anti-coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) at 180 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin', 'description': 'TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). 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'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Unknown/not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Mycosis fungoides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Sezary Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Retro-CLIPI', 'classes': [{'title': 'High risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Low risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risk stratification using the Retrospective Cutaneous Lymphoma International Prognostic Index (Retro-CLIPI).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants who completed assigned treatment'}, {'title': 'Time from diagnosis to allogeneic HCT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 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'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Visceral (site: tonsil)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants may have had more than one active disease', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants who completed assigned treatment'}, {'title': 'Donor', 'classes': [{'title': 'Sibling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Unrelated - matched', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Unrelated - unmatched', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants who completed assigned treatment'}, {'title': 'Donor-recipient cytomegalovirus (CMV) status', 'classes': [{'title': 'Donor and/or recipient seropositive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Donor and recipient seronegative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants who completed assigned treatment'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-07', 'size': 1136414, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-27T19:04', 'hasProtocol': True}, {'date': '2019-03-13', 'size': 527384, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-18T18:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2009-05-07', 'resultsFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2009-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-09', 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) at 180 Days', 'timeFrame': '180 days', 'description': 'Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Acute Graft-versus-host Disease (GVHD)', 'timeFrame': '6 months', 'description': 'Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria.'}, {'measure': 'Number of Participants With Chronic Graft-versus-host Disease (GVHD)', 'timeFrame': '2 years', 'description': 'Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).'}, {'measure': 'Mortality', 'timeFrame': 'Up to 5 years', 'description': 'Total count of non-relapsed mortality and mortality from relapsed disease.'}, {'measure': 'Treatment Related Mortality', 'timeFrame': 'Up to 5 years'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': '2 years', 'description': 'Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': '5 years', 'description': 'Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mycoses', 'Sezary Syndrome', 'Lymphoma, T-Cell, Cutaneous', 'Bone Marrow Transplant Failure', 'Lymphoma, Non-Hodgkin', 'Cutaneous T-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '25529383', 'type': 'BACKGROUND', 'citation': 'Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.'}, {'pmid': '7581076', 'type': 'BACKGROUND', 'citation': 'Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.'}, {'pmid': '32941647', 'type': 'RESULT', 'citation': 'Weng WK, Arai S, Rezvani A, Johnston L, Lowsky R, Miklos D, Shizuru J, Muffly L, Meyer E, Negrin RS, Wang E, Almazan T, Million L, Khodadoust M, Li S, Hoppe RT, Kim YH. Nonmyeloablative allogeneic transplantation achieves clinical and molecular remission in cutaneous T-cell lymphoma. Blood Adv. 2020 Sep 22;4(18):4474-4482. doi: 10.1182/bloodadvances.2020001627.'}, {'pmid': '24307695', 'type': 'DERIVED', 'citation': 'Weng WK, Armstrong R, Arai S, Desmarais C, Hoppe R, Kim YH. Minimal residual disease monitoring with high-throughput sequencing of T cell receptors in cutaneous T cell lymphoma. Sci Transl Med. 2013 Dec 4;5(214):214ra171. doi: 10.1126/scitranslmed.3007420.'}]}, 'descriptionModule': {'briefSummary': 'Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).', 'detailedDescription': 'Primary Objectives\n\n-To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.\n\nSecondary Objectives\n\n-To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.\n2. Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.\n3. Age \\> 18 years and \\<= 75 years.\n4. Karnofsky Performance Status \\>= 70%.\n5. Corrected DLCO \\>= 40%\n6. Left ventricle ejection fraction (LVEF) \\> 30%.\n7. ALT and AST must be \\<= 3X normal. Total bilirubin \\<= 3 mg/dL unless hemolysis or Gilbert's disease.\n8. Estimated creatinine clearance \\>= 50 ml/min.\n9. Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.\n10. Signed informed consent.\n11. Patients with prior malignancies diagnosed \\> 5 years ago without evidence of disease are eligible.\n12. Patients with a prior malignancy treated \\< 5 years ago but have a life expectancy of \\> 5 years for that malignancy are eligible.\n\nDonor Inclusion Criteria\n\n1. Age \\>=17.\n2. HIV seronegative.\n3. No contraindication to the administration of G-CSF.\n4. Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate\n\nExclusion Criteria:\n\n1. Uncontrolled active infection.\n2. Uncontrolled congestive heart failure or angina.\n3. Pregnancy or nursing patients will be excluded from the study.\n4. Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.\n\nDonor Exclusion Criteria\n\n1. Serious medical or psychological illness.\n2. Pregnant or lactating women are not eligible\n3. Prior malignancies within the last 5 years except for non-melanoma skin cancers"}, 'identificationModule': {'nctId': 'NCT00896493', 'briefTitle': 'Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma', 'orgStudyIdInfo': {'id': 'IRB-16213'}, 'secondaryIdInfos': [{'id': 'SU-04062009-2138', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': '16213', 'type': 'OTHER', 'domain': 'Stanford IRB'}, {'id': 'BMT206', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total lymphoid irradiation & anti-thymocyte immunoglobulin', 'description': 'TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.', 'interventionNames': ['Drug: anti-thymocyte globulin', 'Drug: cyclosporine', 'Radiation: Lymphoid radiation']}], 'interventions': [{'name': 'anti-thymocyte globulin', 'type': 'DRUG', 'otherNames': ['ATG'], 'description': 'ATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg', 'armGroupLabels': ['Total lymphoid irradiation & anti-thymocyte immunoglobulin']}, {'name': 'cyclosporine', 'type': 'DRUG', 'otherNames': ['cyclosporin', 'cyclosporin A'], 'description': '5 mg/kg PO or IV', 'armGroupLabels': ['Total lymphoid irradiation & anti-thymocyte immunoglobulin']}, {'name': 'Lymphoid radiation', 'type': 'RADIATION', 'otherNames': ['Total lymphoid irradiation (TLI)'], 'description': 'TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1', 'armGroupLabels': ['Total lymphoid irradiation & anti-thymocyte immunoglobulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Wen-Kai Weng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Wen-Kai Weng', 'investigatorAffiliation': 'Stanford University'}}}}