A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
Universitaetsklinikum Giessen und Marburg /ID# 245308 35043 Marburg (Hessen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Regensburg /ID# 244517 93042 Regensburg (Bayern) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Wuerzburg /ID# 245453 97080 Wuerzburg (Bayern) GermanyRekrutierend» Google-MapsUniversity of Arizona Cancer Center - North Campus /ID# 242219 85719-1478 Tucson United StatesRekrutierend» Google-MapsYale University School of Medicine /ID# 242089 06510 New Haven United StatesRekrutierend» Google-MapsChristiana Care Health Service /ID# 242301 19713 Newark United StatesRekrutierend» Google-MapsTampa General Hospital /ID# 246748 33606 Tampa United StatesRekrutierend» Google-MapsEmory University /ID# 242153 30322-1013 Atlanta United StatesRekrutierend» Google-MapsUniversity of Maryland Medical Center /ID# 242218 21201 Baltimore United StatesRekrutierend» Google-MapsAlliance for Multispecialty Research (AMR) - Kansas City /ID# 242144 64114-4859 Kansas City United StatesRekrutierend» Google-MapsNorthwell Health - 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Skejby /ID# 242670 8200 Aarhus DenmarkRekrutierend» Google-MapsAalborg University Hospital /ID# 242734 9000 Aalborg DenmarkRekrutierend» Google-MapsCHU Clermont-Ferrand /ID# 242344 63100 Clermont FranceRekrutierend» Google-MapsCHU de Rennes - PONTCHAILLOU /ID# 242339 35000 Rennes FranceRekrutierend» Google-MapsInstitut de Recherche Saint Louis - Hopital St Louis /ID# 242336 75010 Paris FranceRekrutierend» Google-MapsCHRU Nancy - Hopitaux de Brabois /ID# 242342 54500 Vandoeuvre-les-Nancy FranceRekrutierend» Google-MapsCHRU Lille - Hopital Claude Huriez /ID# 242335 59037 Lille FranceRekrutierend» Google-MapsCHU de Nantes, Hotel Dieu -HME /ID# 242345 44000 Nantes FranceRekrutierend» Google-MapsHCL - Hopital Lyon Sud /ID# 242349 69495 Pierre Benite CEDEX FranceRekrutierend» Google-MapsHôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 242337 94010 Créteil FranceRekrutierend» Google-MapsHopital Pitie Salpetriere /ID# 242343 75013 Paris FranceRekrutierend» Google-MapsIUCT Oncopole /ID# 242340 31059 Toulouse Cedex 9 FranceRekrutierend» Google-MapsDebreceni Egyetem-Klinikai Kozpont /ID# 242450 4032 Debrecen HungaryRekrutierend» Google-MapsSomogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935 7400 Kaposvár HungaryRekrutierend» Google-MapsSemmelweis Egyetem /ID# 242454 1085 Budapest HungaryRekrutierend» Google-MapsOrszagos Onkologiai Intezet /ID# 242458 1122 Budapest HungaryRekrutierend» Google-MapsThe Chaim Sheba Medical Center /ID# 243010 5265601 Ramat Gan IsraelRekrutierend» Google-MapsTel Aviv Sourasky Medical Center /ID# 243012 6423906 Tel Aviv IsraelRekrutierend» Google-MapsHadassah Medical Center-Hebrew University /ID# 243013 91120 Jerusalem IsraelRekrutierend» Google-MapsRabin Medical Center /ID# 243014 4941492 Haifa IsraelRekrutierend» Google-MapsHokkaido University Hospital /ID# 248999 060-8648 Sapporo-shi JapanRekrutierend» Google-MapsKyoto University Hospital /ID# 248997 606-8507 Kyoto-shi JapanRekrutierend» Google-MapsNational Cancer Center Hospital /ID# 248995 104-0045 Chuo-ku JapanRekrutierend» Google-MapsSeoul National University Bundang Hospital /ID# 242404 13620 Seongnam-si Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center /ID# 242400 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital /ID# 242402 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center /ID# 242401 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsDuplicate_Erasmus Medisch Centrum /ID# 243315 3015 GD Rotterdam NetherlandsAbgeschlossen» Google-MapsVrije Universiteit Medisch Centrum /ID# 243319 1081 HV Amsterdam NetherlandsRekrutierend» Google-MapsUniversitair Medisch Centrum Groningen /ID# 243318 9713 GZ Groningen NetherlandsRekrutierend» Google-MapsLeids Universitair Medisch Centrum /ID# 243316 2333 ZA Leiden NetherlandsRekrutierend» Google-MapsMaastricht Universitair Medisch Centrum /ID# 243317 6229 HX Maastricht NetherlandsRekrutierend» Google-MapsInstituto Catalan de Oncologia (ICO) Badalona /ID# 243265 08916 Badalona SpainRekrutierend» Google-MapsInstituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261 08908 Hospitalet de Llobregat SpainRekrutierend» Google-MapsClinica Universidad de Navarra - 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1. Number of Participants with Dose-Limiting Toxicities (DLT) (Time Frame - Up to Approximately 5 Years): DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Secondary outcome:
1. Best Overall Response (BOR) per Investigator (Time Frame - Up to Approximately 5 Years): BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.
2. Duration of response (DOR) per Investigator (Time Frame - Up to Approximately 5 Years): DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.
3. Number of Participants with Progression-free survival (PFS) (Time Frame - Up to Approximately 5 Years): PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
4. Percentage of Participants with Complete Response (CR) (Time Frame - Up to Approximately 5 Years): CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
5. Time-to-response (TTR) (Time Frame - Up to Approximately 5 Years): TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.
6. Time to Next Antilymphoma Therapy (TTNT) (Time Frame - Up to Approximately 5 Years): Time to next antilymphoma therapy.
7. Rate of Minimal Residual Disease (MRD) Negativity (Time Frame - Up to Approximately 5 Years): MRD is defined as the percentage of participants with assessment of the minimal residual disease.
8. Overall Survival (OS) (Time Frame - Up to Approximately 5 Years): (OS) is defined as the time in months from first dose of epcoritamab to death from any cause.
Experimental: Arm 1: Dose Escalation Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.
Experimental: Arm 2: Dose Escalation Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Experimental: Arm 3: Dose Escalation Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Experimental: Arm 4: Dose Escalation Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Experimental: Arm 5: Dose Escalation Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Experimental: Arm 6A: Dose Escalation Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Experimental: Arm 6B: Dose Escalation Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Experimental: Arm 7: Dose Escalation Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Experimental: Arm 1: Dose Expansion Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.
Experimental: Arm 2: Dose Expansion Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Experimental: Arm 3: Dose Expansion Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Experimental: Arm 4: Dose Expansion Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Experimental: Arm 5: Dose Expansion Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Experimental: Arm 6: Dose Expansion Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Experimental: Arm 7: Dose Expansion Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
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"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma"
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