Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 7:02 AM
Study NCT ID:
NCT01241734
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2010-11-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joshua.zenreich@hmhn.org', 'phone': '5519964248', 'title': 'Joshua Zenreich', 'organization': 'Hackensack Meridan Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level. A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.'}}, 'adverseEventsModule': {'description': 'Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level', 'eventGroups': [{'id': 'EG000', 'title': 'RICE + Lenalidomide', 'description': 'RICE + Lenalidomide days 1-7', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 2, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'RSV Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary Primary Malignancy (+MDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever (absence of neutropenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis (Gram Positive)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revlimid (Lenalidomide) in Combination', 'description': 'Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation\n\nRevlimid: Stage I:\n\nCohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7\n\nStage II:\n\nRICE + Lenalidomide at the MTD days 1-7\n\nStage III:\n\nLenalidomide 25mg days 1-21 every 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 of Treatment (28 Days)', 'description': 'Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stage II - Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 2 Cycles of Treatment (28 Day Cycles)', 'description': 'Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage II', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients enrolled in Stage II analyzed'}, {'type': 'PRIMARY', 'title': 'Stage III - Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'timeFrame': 'After 2 Cycles of Treatment (28 Day Cycles)', 'description': 'Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage III', 'reportingStatus': 'POSTED', 'populationDescription': 'No Stage III Participants Enrolled'}, {'type': 'SECONDARY', 'title': 'Stage I - Dose Limiting Toxicity Incidence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 of Treatment (28 Days)', 'description': 'Incidence of DLT in patients enrolled in stage I for determination of MTD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Rate of DLTs occurred in Stage I Participants'}, {'type': 'SECONDARY', 'title': 'Stage II - 1 Year Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 Year', 'description': 'Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients enrolled in Stage II analyzed'}, {'type': 'SECONDARY', 'title': 'Stage II - 2 Year Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 Years', 'description': 'Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients enrolled in Stage II analyzed'}, {'type': 'SECONDARY', 'title': 'Stage II - 1 Year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 Year', 'description': '1 Year Overall Survival (OS) of patients enrolled in stage II', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients enrolled in stage II analyzed'}, {'type': 'SECONDARY', 'title': 'Stage II - 2 Year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': '2 Year Overall Survival (OS) of patients enrolled in stage II', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients enrolled in stage II analyzed'}, {'type': 'SECONDARY', 'title': 'Stage III - Progression Free Survival (PFS) Rate Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'timeFrame': '2 Years Post Transplant', 'description': 'Rate of Progression Free Survival (PFS) 2 years post Transplant', 'reportingStatus': 'POSTED', 'populationDescription': 'No Stage III Participants Enrolled'}, {'type': 'SECONDARY', 'title': 'Stage III - Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'OG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'OG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'OG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'OG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'timeFrame': '2 Years Post Transplant', 'description': '2 Year Overall Survival (OS) of patients enrolled in stage III', 'reportingStatus': 'POSTED', 'populationDescription': 'No Stage III Participants Enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'FG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'FG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'FG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'FG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '2010-2015'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage I, Cohort 1', 'description': 'RICE + Lenalidomide 10mg days 1-7'}, {'id': 'BG001', 'title': 'Stage I, Cohort 2', 'description': 'RICE + Lenalidomide 15mg days 1-7'}, {'id': 'BG002', 'title': 'Stage I, Cohort 3', 'description': 'RICE + Lenalidomide 20mg days 1-7'}, {'id': 'BG003', 'title': 'Stage I, Cohort 4', 'description': 'RICE + Lenalidomide 25mg days 1-7'}, {'id': 'BG004', 'title': 'Stage II', 'description': 'RICE + Lenalidomide 25mg (MTD) days 1-7'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '75'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '62'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '72'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '65'}, {'value': '51', 'groupId': 'BG004', 'lowerLimit': '22', 'upperLimit': '68'}, {'value': '61.5', 'groupId': 'BG005', 'lowerLimit': '22', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2010-11-15', 'resultsFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-22', 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability', 'timeFrame': 'Cycle 1 of Treatment (28 Days)', 'description': 'Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only'}, {'measure': 'Stage II - Overall Response Rate', 'timeFrame': 'After 2 Cycles of Treatment (28 Day Cycles)', 'description': 'Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage II'}, {'measure': 'Stage III - Overall Response Rate', 'timeFrame': 'After 2 Cycles of Treatment (28 Day Cycles)', 'description': 'Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage III'}], 'secondaryOutcomes': [{'measure': 'Stage I - Dose Limiting Toxicity Incidence Rate', 'timeFrame': 'Cycle 1 of Treatment (28 Days)', 'description': 'Incidence of DLT in patients enrolled in stage I for determination of MTD'}, {'measure': 'Stage II - 1 Year Progression Free Survival (PFS)', 'timeFrame': 'Up to 1 Year', 'description': 'Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II'}, {'measure': 'Stage II - 2 Year Progression Free Survival (PFS)', 'timeFrame': 'Up to 2 Years', 'description': 'Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II'}, {'measure': 'Stage II - 1 Year Overall Survival (OS)', 'timeFrame': 'Up to 1 Year', 'description': '1 Year Overall Survival (OS) of patients enrolled in stage II'}, {'measure': 'Stage II - 2 Year Overall Survival (OS)', 'timeFrame': 'Up to 2 years', 'description': '2 Year Overall Survival (OS) of patients enrolled in stage II'}, {'measure': 'Stage III - Progression Free Survival (PFS) Rate Post Transplant', 'timeFrame': '2 Years Post Transplant', 'description': 'Rate of Progression Free Survival (PFS) 2 years post Transplant'}, {'measure': 'Stage III - Overall Survival (OS)', 'timeFrame': '2 Years Post Transplant', 'description': '2 Year Overall Survival (OS) of patients enrolled in stage III'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diffuse Large B cell Lymphoma'], 'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival.\n\nHypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.', 'detailedDescription': 'This is a 3-Stage, phase I/II, single-arm, open-label study. The first and second stage of the study will assess the safety and efficacy of lenalidomide, rituximab, Ifosfamide, etoposide, and carboplatin (RICER) for the treatment of DLBCL patients in first relapse. The third stage of the study will assess the safety and efficacy of post-autologous stem cell transplantation (ASCT) lenalidomide maintenance in patients with DLBCL.\n\nIn stage I of the study, escalating doses of lenalidomide (10, 15, 20, and 25 mg daily x 7 days on Days 1-7) along with RICE therapy will be given to cohorts of subjects in a standard 3+3 design (see section 5.4.2 for dose escalation schema) until the maximum tolerated dose (MTD) has been determined.\n\nIn stage II, all subjects will be given RICE plus the MTD of lenalidomide. The starting dose of lenalidomide in Stage II will be modified for reduced renal function as outlined in Section 5.4.2.\n\nIn both stage I and stage II, subjects who have stable disease or progression of disease after 2 cycles of RICER will be taken off study. Subjects who achieve \\> PR to 2 cycles of RICER will receive a third cycle followed by stem cell collection and ASCT.\n\nEach cycle is 14 days. Delays in initiating a new cycle are allowed up to 14 days for Stages I and II. The planned number of cycles is 3.\n\nAfter the second cycle, restaging with positron emission tomography (PET) and computerized tomography (CT) scans is performed. Patients with progressive disease are removed from the study, chemosensitive patients (CR/Cru and PR) proceed with third cycle of RICER. Stem cell collection will be completed within 10-14 days after third cycle of RICER. HDCMT-autoSCT will be performed after patient recovers from stem cell collection toxicities. High dose chemotherapy (HDCMT) followed by autologous stem cell transplant (autoSCT) involves administration of chemotherapy with BCNU, Etoposide, Ara-C, Melphalan (BEAM) followed by infusion of autologous stem cells. Involved-field radiation to the sites of bulky disease will be allowed prior to HDCMT-SCT.\n\nStage III, after recovery from aSCT, but not to exceed 90 days all eligible subjects will receive lenalidomide maintenance therapy (po daily on Days 1-21 q28 days) for up to 1 year. Delays in initiating a new cycle up to 28 days are allowed in Stage III. Subjects will be followed for progression- free survival and overall survival for up to 2 years. The starting dose of lenalidomide maintenance treatment will be based on calculated creatinine clearance within 28 days prior to the start of lenalidomide maintenance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Understand and voluntarily sign an informed consent form.\n\n1. Age 18 years at the time of signing the informed consent form.\n2. Able to adhere to the study visit schedule and other protocol requirements.\n3. Histologically confirmed diffuse large B cell lymphoma\n4. Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.\n5. Measurable disease with at least on bidimensional lymph node or tumor mass \\>1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT\n6. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease\n7. Eligible for autologous stem cell transplant\n8. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 2 at study entry (see Appendix B).\n10. Laboratory test results within these ranges:\n\n * Absolute neutrophil count \\>1000 /mm³\n * Platelet count \\> 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of ≥ 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance \\> 30ml/min and \\< 60ml/min.\n * Total bilirubin \\< 1.5 x Upper Limit of Normal (ULN).\n * Aspartate Aminotransferase (SGOT) and Alanine Aminotransferase (SGPT) \\< 3 x ULN.\n11. Disease free of prior malignancies for \\> 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.\n12. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.\n13. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.\n14. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin).\n\n \\-\n\nExclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n\n1. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).\n2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.\n3. Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.\n4. Use of any other experimental drug or therapy within 28 days of baseline.\n5. Known hypersensitivity to thalidomide.\n6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.\n7. Concurrent use of other nonprotocol anti-cancer agents or treatments.\n8. Known positive for HIV or active infectious hepatitis, type B or C.\n9. Refusal of autologous stem cell transplant.\n10. Patients with active central nervous system involvement based on clinical evaluation. Previously treated central nervous system (CNS) involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture.\n11. Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator.\n12. Prior Lenalidomide exposure for more than 28 days.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01241734', 'acronym': 'RICER', 'briefTitle': 'Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Phase I/II Study of Lenalidomide in Combination With Rituximab, Ifosfamide, Etoposide, and Carboplatin (RICER)', 'orgStudyIdInfo': {'id': 'Pro00001132 - RV-DLBCL-PI-0463'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Revlimid (Lenalidomide) in Combination', 'description': 'Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation', 'interventionNames': ['Drug: Revlimid']}], 'interventions': [{'name': 'Revlimid', 'type': 'DRUG', 'otherNames': ['Lenalidomide'], 'description': 'Stage I:\n\nCohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7\n\nStage II:\n\nRICE + Lenalidomide at the MTD days 1-7\n\nStage III:\n\nLenalidomide 25mg days 1-21 every 28 days', 'armGroupLabels': ['Revlimid (Lenalidomide) in Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Tatyana Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}