Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 1:21 AM
Study NCT ID:
NCT01097057
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2010-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D007937', 'term': 'Leukapheresis'}, {'id': 'C088327', 'term': 'plerixafor'}, {'id': 'C049051', 'term': 'ferric pyrophosphate'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D016238', 'term': 'Cytapheresis'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D047589', 'term': 'Leukocyte Reduction Procedures'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lholmber@fredhutch.org', 'phone': '206-667-6447', 'title': 'Dr. Leona A. Holmberg', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 5, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'DVT', 'notes': 'Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Asymptomatic line-associated DVT requiring therapeutic anticoagulant.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Cellulitis at Hickman site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'notes': 'Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. One patient had both hyperglycemia and cellulitis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'notes': 'No treatment related deaths', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'notes': 'No treatment related deaths', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One Month', 'description': 'Number of patients who achieved ≥5 x 10\\^6 CD34 cells/kg autologous PBSC collection by apheresis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of patients to collect at least 5 x 10\\^6 CD34 cells/kg in under 4 apheresis procedures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'classes': [{'title': 'One apheresis collection day', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Two apheresis collection days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Three apheresis collection days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Four apheresis collection days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of participants requiring one or two apheresis collection days to reach collection goal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of participants who did not collect ≥5 x 10\\^6 CD34 cells/kg in up to four apheresis days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: No patients were in this category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nCarboplatin: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nIfosfamide: Given IV\n\nLeukapheresis: Given through catheter\n\nPlerixafor: Given SC\n\nRituximab: Given IV'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-28', 'studyFirstSubmitDate': '2010-03-30', 'resultsFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-01', 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)', 'timeFrame': 'One Month', 'description': 'Number of patients who achieved ≥5 x 10\\^6 CD34 cells/kg autologous PBSC collection by apheresis.'}, {'measure': 'Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of patients to collect at least 5 x 10\\^6 CD34 cells/kg in under 4 apheresis procedures.'}, {'measure': 'Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of participants requiring one or two apheresis collection days to reach collection goal.'}, {'measure': 'Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days', 'timeFrame': 'Up to Four Apheresis Days', 'description': 'Number of participants who did not collect ≥5 x 10\\^6 CD34 cells/kg in up to four apheresis days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.", 'detailedDescription': "OBJECTIVES:\n\nI. Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen \\[R-ICE regimen\\]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach \\>= 5 x 10\\^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if \\>= 5 x 10\\^6 CD34 cells/kg is not obtained.\n\nOUTLINE:\n\nPatients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.\n\nAfter completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of CD20+ non-Hodgkin's lymphoma\n* Left ventricular ejection fraction at rest \\>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram\n* Bilirubin =\\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\< 3 times the upper limit of normal\n* Creatinine clearance (calculated creatinine clearance is permitted) \\> 50 mL/min\n* Signed informed consent\n* Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)\n\nExclusion Criteria:\n\n* Karnofsky performance score \\< 70%\n* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)\n* Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \\> 5 years previously will be allowed\n* Pregnant or breastfeeding\n* Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization\n* Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)\n* Human immunodeficiency virus (HIV) positive\n* Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study\n* Hepatitis B carriers"}, 'identificationModule': {'nctId': 'NCT01097057', 'briefTitle': 'Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor', 'orgStudyIdInfo': {'id': '2310.00'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01562', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2310.00', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (rituximab, etoposide, carboplatin, ifosfamide)', 'description': 'Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Etoposide', 'Biological: Filgrastim', 'Drug: Ifosfamide', 'Procedure: Leukapheresis', 'Drug: Plerixafor', 'Biological: Rituximab']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'Nealorin', 'Novoplatinum', 'Paraplat', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16-213', 'VP-16', 'VP-16-213'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Filgrastim XM02', 'G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tbo-filgrastim', 'Tevagrastim'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Ifosfamide', 'type': 'DRUG', 'otherNames': ['Asta Z 4942', 'Asta Z-4942', 'Cyfos', 'Holoxan', 'Holoxane', 'Ifex', 'IFO', 'IFO-Cell', 'Ifolem', 'Ifomida', 'Ifomide', 'Ifosfamidum', 'Ifoxan', 'IFX', 'Iphosphamid', 'Iphosphamide', 'Iso-Endoxan', 'Isoendoxan', 'Isophosphamide', 'Mitoxana', 'MJF 9325', 'MJF-9325', 'Naxamide', 'Seromida', 'Tronoxal', 'Z 4942', 'Z-4942'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Leukapheresis', 'type': 'PROCEDURE', 'otherNames': ['Leukocytopheresis', 'Therapeutic Leukopheresis'], 'description': 'Given through catheter', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Plerixafor', 'type': 'DRUG', 'otherNames': ['AMD 3100', 'JM-3100', 'Mozobil', 'SDZ SID 791'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['BI 695500', 'C2B8 Monoclonal Antibody', 'Chimeric Anti-CD20 Antibody', 'IDEC-102', 'IDEC-C2B8', 'IDEC-C2B8 Monoclonal Antibody', 'MabThera', 'Monoclonal Antibody IDEC-C2B8', 'PF-05280586', 'Rituxan', 'Rituximab Biosimilar BI 695500', 'Rituximab Biosimilar PF-05280586', 'Rituximab Biosimilar RTXM83', 'RTXM83'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (rituximab, etoposide, carboplatin, ifosfamide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Leona Holmberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leona Holmberg', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}