Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-01 @ 11:07 PM
Study NCT ID:
NCT00039195
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2002-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'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'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moskowic@mskcc.org', 'phone': '212-639-7992', 'title': 'Dr. Craig Moskowitz', 'organization': 'Memorial Slaon Kettering'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Induction R-CHOPac Therapy', 'description': 'Induction R-CHOPac Therapy for patients with B-Cell Lymphoma', 'otherNumAtRisk': 98, 'otherNumAffected': 98, 'seriousNumAtRisk': 98, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hemoglobin (Hgb)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 89, 'numAffected': 89}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 79, 'numAffected': 79}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Infection without neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 68, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 94, 'numAffected': 94}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 64, 'numAffected': 64}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Prothrombin time (PT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Partial thromboplastin time (PTT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'SGOT (AST)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'SGPT (ALT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}], 'seriousEvents': [{'term': 'Abdominal pain/cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Arachnoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Constitutional symptoms, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Delusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'GI, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hemoglobin (Hgb)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hemorrhage, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Ileus (or neuroconstipation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Infection without neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Radiation mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Pain - Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Pulmonary, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Supravent arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction R-CHOPac Therapy', 'description': 'Induction R-CHOPac Therapy for patients with B-Cell Lymphoma'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Kaplan-Meier estimates will be used to verify the progression free survival.', 'unitOfMeasure': 'percentage of patients progression free', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Induction R-CHOPac Therapy', 'description': 'Induction R-CHOPac Therapy for patients with B-Cell Lymphoma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Induction R-CHOPac Therapy', 'description': 'Induction R-CHOPac Therapy for patients with B-Cell Lymphoma'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2002-06-06', 'resultsFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-29', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '2 years', 'description': 'Kaplan-Meier estimates will be used to verify the progression free survival.'}]}, 'conditionsModule': {'keywords': ['stage I adult diffuse large cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '38271621', 'type': 'DERIVED', 'citation': 'Bantilan KS, Smith AN, Maurer MJ, Teruya-Feldstein J, Matasar MJ, Moskowitz AJ, Straus DJ, Noy A, Palomba ML, Horwitz SM, Hamlin PA, Portlock CS, Cerhan JR, Habermann TM, Salles GA, Nowakowski GS, Moskowitz CH, Zelenetz AD. Matched control analysis suggests that R-CHOP followed by (R)-ICE may improve outcome in non-GCB DLBCL compared with R-CHOP. Blood Adv. 2024 May 14;8(9):2172-2181. doi: 10.1182/bloodadvances.2023011408.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.', 'detailedDescription': 'OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate or high).\n\nPatients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion. Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy. Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter the completion of induction chemotherapy, patients undergo CT scan and positron emission tomography (PET) scanning. If the PET scan is positive in one or more nodal sites, a repeat biopsy is performed. Patients with a negative PET scan OR a negative repeat biopsy (including no evidence of lymphoma on repeat bone marrow biopsy) are assigned to receive regimen A for consolidation therapy. Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy.\n\n* Regimen A: Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3, ifosfamide IV continuously over 24 hours on day 2, carboplatin IV on day 2, and G-CSF SC once daily on days 5-12 or PEG-filgrastim once at least 24 hours after infusion. Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.\n* Regimen B: Patients receive consolidation chemotherapy as in regimen A for 3 courses. Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy. Patients undergo leukapheresis at the completion of course 3 (G-CSF continues from day 5 until the end of leukapheresis). After completion of leukapheresis, patients begin a regimen of high-dose chemoradiotherapy comprising either total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2 or BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and melphalan. Autologous peripheral blood stem cells (APBSC) are reinfused on day 0. Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. Beginning on day 42 post-APBSC, if blood counts have recovered, patients receive rituximab IV once weekly for 4 weeks. Rituximab is repeated beginning on day 180 in the absence of disease progression.\n\nPatients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation. All patients are followed closely for 5 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 40-98 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed aggressive diffuse large B-cell lymphoma\n* CD20-positive disease\n* Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:\n\n * Karnofsky performance status 10-70%\n * Lactate dehydrogenase greater than 200 U/L\n * Stage III or IV disease\n* Positron emission tomography avid measurable disease\n* No CNS involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 64\n\nPerformance status:\n\n* See Disease Characteristics\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1,000/mm\\^3\n* Platelet count greater than 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease\n* Hepatitis B surface antigen and hepatitis C antibody negative\n* No chronic, active, or persistent hepatitis\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance greater than 60 mL/min\n* No chronic renal insufficiency\n\nCardiovascular:\n\n* Ejection fraction at least 50% by echocardiogram or MUGA scan\n* No myocardial infarction within the past 6 months\n* No unstable angina\n* No cardiac arrhythmias except chronic atrial fibrillation\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* HIV negative\n* No other medical illness that would preclude study\n* No uncontrolled infection\n* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior biologic therapy for malignancy\n\nChemotherapy:\n\n* No prior chemotherapy for malignancy\n\nEndocrine therapy:\n\n* Prior steroids allowed if received no more than 1 week of therapy\n\nRadiotherapy:\n\n* No prior radiotherapy for malignancy\n\nSurgery:\n\n* No prior surgery for malignancy\n\nOther:\n\n* No other prior therapy for malignancy"}, 'identificationModule': {'nctId': 'NCT00039195', 'briefTitle': 'Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma', 'orgStudyIdInfo': {'id': '01-142'}, 'secondaryIdInfos': [{'id': 'MSKCC-01142'}, {'id': 'NCI-G02-2069'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction R-CHOPac Therapy for patients with B-Cell Lymphoma', 'description': 'Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy.', 'interventionNames': ['Biological: filgrastim', 'Biological: rituximab', 'Drug: carboplatin', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: ifosfamide', 'Drug: prednisone', 'Drug: vincristine sulfate', 'Procedure: peripheral blood stem cell transplantation', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'rituximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'etoposide', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'ifosfamide', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'prednisone', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Induction R-CHOPac Therapy for patients with B-Cell Lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Craig Moskowitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}