Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00928018
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2009-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parmand@partners.org', 'phone': '617-632-2305', 'title': 'Philippe Armand, MD, PhD', 'organization': 'Dana Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. The study defined follow up period is 2 years.', 'description': "All AEs grades 3-5 and SAEs whether reported by participant, discovered during questioning, directly observed, or detected by physical examination, laboratory test, etc, will be recorded in participant's medical record and appropriate study-specific forms\n\nOnly events reported in \\>1 patient on at least one of the arms are listed in Other AE table", 'eventGroups': [{'id': 'EG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months', 'otherNumAtRisk': 66, 'otherNumAffected': 41, 'seriousNumAtRisk': 66, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months', 'otherNumAtRisk': 73, 'otherNumAffected': 54, 'seriousNumAtRisk': 73, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'TMA/renal failure/hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Confusion/psychosis/encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Stomatitis/mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}], 'seriousEvents': [{'term': 'Other: Relapse/Progressive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Treatment Related Secondary Malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombotic Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Supraventricular and Nodal Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Obstuction--GI, small bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Liver failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Other- Systemic inflammatory response syndrome (SIRS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hemorrhage, CNS (cerebrovascular)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Acute Kidney Injury/Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Adult Respiratory Distress Syndrome (ARDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Other--Respiratory failure/lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Other--Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'OG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '79'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare 2-year Progression-free Survival Between the Two Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'OG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '71'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'OG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'classes': [{'title': 'Cumulative incidence of relapse/progression', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '37'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '41'}]}]}, {'title': 'Non-relapse mortality', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '23'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'OG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'classes': [{'title': 'Grade II-IV aGVHD', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Grade III-IV aGVHD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'OG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indolent Group: Sirolimus-Containing Regimen', 'description': 'Indolent group:indolent B-cell NHL, CLL and HL histologies\n\nThe Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant'}, {'id': 'OG001', 'title': 'Indolent Group: Sirolimus-Free Regimen', 'description': 'Indolent group: indolent B-cell NHL, CLL and HL histologies\n\nThere are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months.'}, {'id': 'OG002', 'title': 'Aggressive Group: Sirolimus-Containing Regimen', 'description': 'Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies\n\nThe Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant'}, {'id': 'OG003', 'title': 'Aggressive Group: Sirolimus-Free Regimen', 'description': 'Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies\n\nThere are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months.'}], 'classes': [{'title': 'Overall Survival', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Progression Free Survival', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'Cumulative Incidence of Progression', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Non-relapse mortality', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'FG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One Arm A patient withdrew consent, treated as Arm B, but analyzed on Arm A based on intent-to-treat', 'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.\n\nSirolimus: Taken orally for at least 12 months\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months'}, {'id': 'BG001', 'title': 'Sirolimus-Free Regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.\n\nMethotrexate: Given intravenously on the first, third and sixth day after transplant\n\nTacrolimus: Taken orally or given intravenously for at least 6 months\n\nCyclosporine: Taken orally or given intravenously for at least 6 months\n\nMMF: Taken orally for about 2 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '70'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '69'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-16', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To Compare 2-year Progression-free Survival Between the Two Treatment Arms', 'timeFrame': '2 years'}, {'measure': 'To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms', 'timeFrame': '2 years'}, {'measure': 'To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms', 'timeFrame': '6 months'}, {'measure': 'To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.', 'timeFrame': '2 years'}, {'measure': 'To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['allogeneic stem cell transplant', 'reduced intensity conditioning', 'graft versus host disease', 'GVHD', 'RIC transplantation'], 'conditions': ['Non-hodgkin Lymphoma', 'Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '26729448', 'type': 'DERIVED', 'citation': 'Armand P, Kim HT, Sainvil MM, Lange PB, Giardino AA, Bachanova V, Devine SM, Waller EK, Jagirdar N, Herrera AF, Cutler C, Ho VT, Koreth J, Alyea EP, McAfee SL, Soiffer RJ, Chen YB, Antin JH. The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial. Br J Haematol. 2016 Apr;173(1):96-104. doi: 10.1111/bjh.13931. Epub 2016 Jan 5.'}]}, 'descriptionModule': {'briefSummary': "This trial is comparing whether using a drug called sirolimus for graft versus host disease (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after transplantation, compared to using a standard GVHD prevention regimen without sirolimus. Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead to a decreased risk of relapse and hence better transplantation outcome.", 'detailedDescription': '* Because no one knows which of the study options is best, participants will be "randomized" into one of the two possible groups for GVHD prophylaxis: 1) a sirolimus-containing regimen (tacrolimus, sirolimus and methotrexate) or 2) a sirolimus-free regimen (tacrolimus and methotrexate or cyclosporine and mycophenolate mofetil).\n* Participants will receive a reduced intensity conditioning regimen. This is done to prepare the body for transplantation. This will consist of a combination of drugs (either fludarabine and busulfan or fludarabine, cyclophosphamide and low-dose total body irradiation). The purpose of these drugs is to weaken the immune system and lower the chance of the body rejecting the donated stem cells.\n* Participants will also receive the GVHD prophylaxis regimen that they have been randomized to. These drugs will lower the chance of rejecting the donor cells and lower the chance of developing GVHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients will be eligible if their primary indication for transplantation is among the following: Indolent B-cell non-Hodgkin lymphoma (NHL); Aggressive B-Cell NHL; T-cell NHL; or Hodgkin Lymphoma.\n* Patients must have one of the following combinations of disease status and disease histology at the time of enrollment: 1) Patients may be transplanted as part of first-line therapy if they have one of the following histologies: CLL with adverse cytogenetics, MCL or, T-cell NHL. 2) Patients may be transplanted as part of treatment for relapsed or refractory disease without a prior autologous transplantation of they have one of the following histologies: Indolent NHL (including CLL/SLL), MCL or T-cell NHL. 3) Patients may be transplanted as part of treatment for disease that has relapsed or progressed after autologous transplantation if they have any of the histologies listed above. Patients may also be enrolled without a prior autologous transplantation if they have a contraindication to autologous transplantation, in the opinion of the treating clinician. 4) There is no minimal or maximal time interval from the patient's last anti-lymphoma therapy and the time of transplantation.\n* 18-72 years of age\n* Matched related or matched unrelated donor\n* Donor willing to donate peripheral blood stem cells and meeting institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to individual transplant center criteria.\n\nExclusion Criteria:\n\n* Patients with Burkitt lymphoma or DLBCL with a c-myc rearrangement\n* Karnofsky performance status of less than 70% at the time of registration\n* Prior allogeneic stem cell transplantation (note that prior autologous stem cell transplantation is allowed)\n* Uncontrolled infection\n* Serum creatinine 2.0mg/dl or greater\n* Total bilirubin 2.0mg/dl or greater (unless related to hemolysis or Gilbert's syndrome)\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times or greater than the institutional upper limit of normal\n* Left ventricular ejection fraction \\< 30%\n* Cholesterol \\> 500mg/dl or triglycerides \\> 500 mg/dl despite appropriate treatment\n* Seropositivity for HIV\n* Pregnancy or breast-feeding (effective contraception must be used during therapy and for at least 6 months after the end of immunosuppressive agents)\n* Prior history of allergy to sirolimus, tacrolimus, cyclosporine, methotrexate or MMF\n* Concomitant treatment with another investigational drug (unless cleared by study chair)"}, 'identificationModule': {'nctId': 'NCT00928018', 'briefTitle': 'Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma', 'orgStudyIdInfo': {'id': '09-073'}, 'secondaryIdInfos': [{'id': 'CA142106', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute/NIH/DHHS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-Containing Regimen', 'description': 'The Sirolimus containing arm will consist of the following drugs:\n\nExperimental Arm: tacrolimus + sirolimus + low-dose methotrexate\n\nTacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nSirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.\n\nMethotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.', 'interventionNames': ['Drug: Sirolimus', 'Drug: Methotrexate', 'Drug: Tacrolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-Free regimen', 'description': 'There are two choices for the Sirolimus free arm:\n\nControl Arm 1: tacrolimus + methotrexate\n\nTacrolimus:Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.\n\nMethotrexate:Administered by intravenous bolus infusion at a dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.\n\nControl Arm 2: cyclosporine + MMF\n\nCyclosporine: administered orally at a dose of 6 mg/kg based on ABW bid starting on day -3.\n\nMMF:administered at a dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting on day 3.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Tacrolimus', 'Drug: Cyclosporine', 'Drug: MMF']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamycin'], 'description': 'Taken orally for at least 12 months', 'armGroupLabels': ['Sirolimus-Containing Regimen']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abbreviated MTX', 'Trade name:Trexall'], 'description': 'Given intravenously on the first, third and sixth day after transplant', 'armGroupLabels': ['Sirolimus-Containing Regimen', 'Sirolimus-Free regimen']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf'], 'description': 'Taken orally or given intravenously for at least 6 months', 'armGroupLabels': ['Sirolimus-Containing Regimen', 'Sirolimus-Free regimen']}, {'name': 'Cyclosporine', 'type': 'DRUG', 'otherNames': ['Brand names:', '•Gengraf', '•Neoral', '•Sandimmune', '•Sangcya'], 'description': 'Taken orally or given intravenously for at least 6 months', 'armGroupLabels': ['Sirolimus-Free regimen']}, {'name': 'MMF', 'type': 'DRUG', 'otherNames': ['Mycophenolate mofetil (MMF)', 'Brand Names:', 'CellCept', 'Myfortic'], 'description': 'Taken orally for about 2 months', 'armGroupLabels': ['Sirolimus-Free regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Philippe Armand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Philippe Armand, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}