protocolSection identificationModule nctId: NCT06356129, orgStudyIdInfo id: CA073-1020, secondaryIdInfos id: 2023-510178-15, type: REGISTRY, domain: EU CT Number, secondaryIdInfos id: U1111-1300-8493, type: REGISTRY, domain: UTN, briefTitle: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma, acronym: GOLSEEK-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-24, primaryCompletionDateStruct date: 2028-08-14, completionDateStruct date: 2029-11-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Celgene, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL)., conditionsModule conditions: Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: Golcadomide, interventions name: Placebo, interventions name: Rituximab, interventions name: Cyclophosphamide, interventions name: Doxorubicin, interventions name: Vincristine, interventions name: Prednisone, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by the Investigator, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC), secondaryOutcomes measure: Minimal residual disease (MRD) negativity rate, secondaryOutcomes measure: Progression-free survival (PFS) assessed by the IRAC, secondaryOutcomes measure: Objective response (OR) assessed by the Investigator, secondaryOutcomes measure: Complete metabolic response (CMR) assessed by the Investigator, secondaryOutcomes measure: PFS24 assessed by the Investigator 24 months after randomization, secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Second progression-free survival (PFS2) assessed by the Investigator, secondaryOutcomes measure: Relative dose intensity (%), secondaryOutcomes measure: Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire, secondaryOutcomes measure: Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire, secondaryOutcomes measure: Mean change from baseline in the EORTC QLQ-C30, secondaryOutcomes measure: Mean change from baseline in the FACT-LymS, secondaryOutcomes measure: Number of participants with Adverse Events (AEs), secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Number of participants with laboratory abnormalities, secondaryOutcomes measure: Number of participants with vital sign abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Local Institution - 0014, city: Mobile, state: Alabama, zip: 36604, country: United States, contacts name: Site 0014, role: CONTACT, geoPoint lat: 30.69436, lon: -88.04305, locations facility: Local Institution - 0342, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Site 0342, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Local Institution - 0287, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Site 0287, role: CONTACT, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Local Institution - 0415, city: Margate, state: Florida, zip: 33063, country: United States, contacts name: Site 0415, role: CONTACT, geoPoint lat: 26.24453, lon: -80.20644, locations facility: Local Institution - 0012, city: Pensacola, state: Florida, zip: 32504, country: United States, contacts name: Site 0012, role: CONTACT, geoPoint lat: 30.42131, lon: -87.21691, locations facility: Local Institution - 0414, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Site 0414, role: CONTACT, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Local Institution - 0303, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Site 0303, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 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0067, city: Minneapolis, state: Minnesota, zip: 55407, country: United States, contacts name: Site 0067, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Local Institution - 0203, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Site 0203, role: CONTACT, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Local Institution - 0437, city: Kansas City, state: Missouri, zip: 64132, country: United States, contacts name: Site 0437, role: CONTACT, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Local Institution - 0466, city: Reno, state: Nevada, zip: 89511, country: United States, contacts name: Site 0466, role: CONTACT, geoPoint lat: 39.52963, lon: -119.8138, locations facility: Local Institution - 0049, city: Morristown, state: New Jersey, zip: 07960, country: United States, contacts name: Site 0049, role: CONTACT, geoPoint lat: 40.79677, lon: -74.48154, locations facility: Local Institution - 0190, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Site 0190, role: CONTACT, geoPoint lat: 42.88645, lon: -78.87837, locations facility: Local Institution - 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0421, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1417DTB, country: Argentina, contacts name: Site 0421, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0112, city: Buenos Aires, zip: 1426, country: Argentina, contacts name: Site 0112, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0136, city: Buenos Aires, zip: C1431FWO, country: Argentina, contacts name: Site 0136, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0119, city: Ciudad Autónoma de Buenos Aires, zip: C1426ANZ, country: Argentina, contacts name: Site 0119, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0111, city: Córdoba, zip: 5016, country: Argentina, contacts name: Site 0111, role: CONTACT, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Local Institution - 0357, city: Gosford, state: New South Wales, zip: 2250, country: Australia, contacts name: Site 0357, role: CONTACT, geoPoint lat: -33.4244, lon: 151.34399, locations facility: Local Institution - 0361, city: Sydney, state: New South Wales, zip: 2560, country: Australia, contacts name: Site 0361, role: CONTACT, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Local Institution - 0358, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Site 0358, role: CONTACT, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Local Institution - 0363, city: Tiwi, state: Northern Territory, zip: 0810, country: Australia, contacts name: Site 0363, role: CONTACT, geoPoint lat: -12.35876, lon: 130.878, locations facility: Local Institution - 0356, city: Birtinya, state: Queensland, zip: 4575, country: Australia, contacts name: Site 0356, role: CONTACT, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Local Institution - 0360, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: Site 0360, role: CONTACT, geoPoint lat: -27.96724, lon: 153.39796, locations facility: Local Institution - 0365, city: Frankston, state: Victoria, zip: 3195, country: Australia, contacts name: Site 0365, role: CONTACT, geoPoint lat: -38.14458, lon: 145.12291, locations facility: Local Institution - 0362, city: Heidelberg, state: Victoria, zip: 3084, country: Australia, contacts name: Site 0362, role: CONTACT, geoPoint lat: -37.75, lon: 145.06667, locations facility: Local Institution - 0359, city: St Albans, state: Victoria, zip: 3021, country: Australia, contacts name: Site 0359, role: CONTACT, geoPoint lat: -37.73901, lon: 144.80024, locations facility: Local Institution - 0364, city: Warrnambool, state: Victoria, zip: 3280, country: Australia, contacts name: Site 0364, role: CONTACT, geoPoint lat: -38.38176, lon: 142.48799, locations facility: Local Institution - 0385, city: Wels, state: Oberösterreich, zip: 4600, country: Austria, contacts name: Site 0385, role: CONTACT, geoPoint lat: 48.16667, lon: 14.03333, locations facility: Local Institution - 0387, city: Linz, zip: 4021, country: Austria, contacts name: Site 0387, role: CONTACT, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Local Institution - 0386, city: Vienna, zip: 1140, country: Austria, contacts name: Site 0386, role: CONTACT, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Local Institution - 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