Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT01370694
Status:
TERMINATED
Last Update Posted:
2019-03-15
First Post:
2011-05-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Philippines', 'Poland', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated for business reasons. Not all planned analyses were performed'}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after last dose of CVP therapy (up to 28 weeks)', 'description': 'Adverse events were not collected for participants who were switched to MabThera.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypercreatininaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of combination therapy up to 24 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving at least one dose of any study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'timeFrame': 'From first dose of single agent MK-8808 up to 2 years', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'timeFrame': 'Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)', 'description': 'Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done due to early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'timeFrame': 'Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)', 'description': 'Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.'}, {'type': 'SECONDARY', 'title': 'Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'timeFrame': 'Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)', 'description': 'Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done due to early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'timeFrame': 'Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)', 'description': 'Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.'}, {'type': 'SECONDARY', 'title': 'Clinical Response of Tumor to MK-8808/CVP Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'classes': [{'title': 'PR', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CRu', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with evaluable data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Switched to rituximab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 on 18 March 2014, but could continue to receive maintenance therapy with rituximab per standard of care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '16.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The study was terminated for business reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2011-05-18', 'resultsFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-23', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy', 'timeFrame': 'From first dose of combination therapy up to 24 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.'}, {'measure': 'Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy', 'timeFrame': 'From first dose of single agent MK-8808 up to 2 years', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP', 'timeFrame': 'Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)', 'description': 'Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.'}, {'measure': 'Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy', 'timeFrame': 'Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)', 'description': 'Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.'}, {'measure': 'Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP', 'timeFrame': 'Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)', 'description': 'Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.'}, {'measure': 'Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance', 'timeFrame': 'Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)', 'description': 'Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.'}, {'measure': 'Clinical Response of Tumor to MK-8808/CVP Combination Therapy', 'timeFrame': 'Up to 2 years', 'description': 'The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=8808-001&kw=8808-001&tab=access', 'type': 'CSR Synopsis Link'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.', 'detailedDescription': 'The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization \\[WHO\\] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.\n* Ann Arbor Stage III or IV disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n* Life expectancy \\>3 months with no expected need of immediate intervention to treat life-threatening complications.\n* Adequate organ function.\n* Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.\n\nExclusion criteria:\n\n* Histological Grade 3b or with \\>50% diffuse architectural pattern.\n* Circulating malignant cells \\>25,000/mm\\^3\n* Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).\n* Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.\n* Radiotherapy within 2 months prior to Cycle 1 Day 1.\n* Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.\n* Concomitant disease that requires continuous therapy with prednisone at doses \\>20 mg per day.\n* Any medical contraindication for prednisolone as being dosed in the CVP regimen.\n* Poorly controlled diabetes mellitus, as defined by institutional or local standards.\n* Grade \\>2 peripheral neuropathy.\n* Has one of the following:\n\n 1. is human immunodeficiency virus (HIV)-positive\n 2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)\n 3. has antibodies to Hepatitis C virus\n* Has one or more of the following:\n\n 1. Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.\n 2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.\n 3. History of a tuberculosis infection.\n* Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.\n* Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.\n* Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT01370694', 'briefTitle': 'Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma', 'orgStudyIdInfo': {'id': '8808-001'}, 'secondaryIdInfos': [{'id': '2011-000386-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-8808 Combination Therapy', 'description': 'Participants received MK-8808 375 mg/m\\^2 intravenously (IV) + cyclophosphamide 750 mg/m\\^2 IV + vincristine 1.4 mg/m\\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.', 'interventionNames': ['Drug: MK-8808', 'Drug: cyclophosphamide', 'Drug: vincristine', 'Drug: prednisolone']}], 'interventions': [{'name': 'MK-8808', 'type': 'DRUG', 'armGroupLabels': ['MK-8808 Combination Therapy']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['MK-8808 Combination Therapy']}, {'name': 'vincristine', 'type': 'DRUG', 'armGroupLabels': ['MK-8808 Combination Therapy']}, {'name': 'prednisolone', 'type': 'DRUG', 'armGroupLabels': ['MK-8808 Combination Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}