A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Universitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyZurückgezogen» Google-MapsUniversitaetsklinikum Regensburg 93053 Regensburg (Bayern) GermanyAktiv, nicht rekrutierend» Google-MapsKatharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin 70174 Stuttgart (Baden-Württemberg) GermanyAktiv, nicht rekrutierend» Google-MapsUniversity of Alabama at Birmingham 35294-3300 Birmingham United StatesAktiv, nicht rekrutierend» Google-MapsBanner Health MD Anderson AZ 85234 Gilbert United StatesZurückgezogen» Google-MapsCommunity Cancer Institute (CCI) 93720 Fresno United StatesAbgeschlossen» Google-MapsBaptist Medical Center - Jacksonville 32207-8202 Jacksonville United StatesAktiv, nicht rekrutierend» Google-MapsBaptist - MD Anderson Cancer Center 32207 Jacksonville United StatesAbgeschlossen» Google-MapsOchsner Medical Center 70121 New Orleans United StatesZurückgezogen» Google-MapsUniversity of Maryland Medical Center 21201 Baltimore United StatesAbgeschlossen» Google-MapsSidney Kimmel Comprehensive Cancer Center at Johns Hopkins 21287 Baltimore United StatesAktiv, nicht rekrutierend» Google-MapsMassachusetts General Hospital 02114 Boston United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Mississippi Medical Center 39216 Jackson United StatesAktiv, nicht rekrutierend» Google-MapsRutgers Cancer Institute of New Jersey 08901 New Brunswick United StatesAbgeschlossen» Google-MapsIcahn School of Medicine at Mount Sinai 10029 New York United StatesAbgeschlossen» Google-MapsDuke University Medical Center 27705 Durham United StatesAktiv, nicht rekrutierend» Google-MapsAllegheny General Hospital 15212 Pittsburgh United StatesZurückgezogen» Google-MapsProvidence Regional Cancer Partnership 98201 Everett United StatesZurückgezogen» Google-MapsPrince of Wales Hospital; Haematology 2031 Randwick AustraliaAktiv, nicht rekrutierend» Google-MapsRoyal Adelaide Hospital; Haematology Clinical Trials 5000 Adelaide AustraliaAktiv, nicht rekrutierend» Google-MapsMonash Health Monash Medical Centre 3168 Clayton AustraliaAktiv, nicht rekrutierend» Google-MapsSt Vincent's Hospital Melbourne 3065 Fitzroy AustraliaAktiv, nicht rekrutierend» Google-MapsPeter Maccallum Cancer Centre 3000 Melbourne AustraliaAktiv, nicht rekrutierend» Google-MapsSir Charles Gairdner Hospital 6009 Nedlands AustraliaAktiv, nicht rekrutierend» Google-MapsUZ Gent 9000 Gent BelgiumZurückgezogen» Google-MapsUZ Leuven Gasthuisberg 3000 Leuven BelgiumAktiv, nicht rekrutierend» Google-MapsCHU Sart-Tilman 4000 Liège BelgiumAktiv, nicht rekrutierend» Google-MapsBeijing Cancer Hospital 100142 Beijing ChinaZurückgezogen» Google-MapsPeking University Third Hospital 100191 Beijing ChinaAktiv, nicht rekrutierend» Google-MapsWest China Hospital, Sichuan University 610041 Chengdu ChinaZurückgezogen» Google-MapsSun Yet-sen University Cancer Center 510663 Guangzhou City ChinaAktiv, nicht rekrutierend» Google-MapsHarbin Medical University Cancer Hospital 150081 Harbin ChinaAktiv, nicht rekrutierend» Google-MapsJiangsu Province Hospital 210008 Nanjing ChinaZurückgezogen» Google-MapsFudan University Shanghai Cancer Center 200120 Shanghai City ChinaRekrutierend» Google-MapsTianjin Cancer Hospital 300060 Tianjin ChinaAktiv, nicht rekrutierend» Google-MapsWuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology 430022 Wuhan City ChinaAktiv, nicht rekrutierend» Google-MapsZhejiang Cancer Hospital 310022 Zhejiang ChinaRekrutierend» Google-MapsHenan Cancer Hospital 450008 Zhengzhou ChinaAktiv, nicht rekrutierend» Google-MapsAarhus Universitetshospital Skejby; Blodsygdomme 8200 Aarhus N DenmarkAbgeschlossen» Google-MapsRigshospitalet; Hæmatologisk Klinik 2100 København Ø DenmarkAktiv, nicht rekrutierend» Google-MapsInstitut Bergonie; Hematologie Oncologie 33076 Bordeaux FranceAktiv, nicht rekrutierend» Google-MapsHopital Henri Mondor; 51 Av Mal Lattre De Tassigny 94010 Creteil FranceAktiv, nicht rekrutierend» Google-MapsHopital Claude Huriez; Hematologie 59037 Lille FranceAktiv, nicht rekrutierend» Google-MapsCHU DE MONTPELLIER-ST ELOI; Département d'Hématologie Clinique 34295 Montpellier FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier Lyon Sud 69495 Pierre Benite FranceAktiv, nicht rekrutierend» Google-MapsCHU Pontchaillou; Service Hématologie 35003 Rennes FranceAbgeschlossen» Google-MapsPusan National University Hospital 602-739 Busan Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsNational Cancer Center 10408 Goyang-si Korea, Republic ofAbgeschlossen» Google-MapsSeoul National University Bundang Hospital 463-707 Seongnam-si Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsUniwersyteckie Centrum Kliniczne Gdansk PolandAktiv, nicht rekrutierend» Google-MapsCentrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli 20-090 Lublin PolandAktiv, nicht rekrutierend» Google-MapsOddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie 10-228 Olsztyn PolandAktiv, nicht rekrutierend» Google-MapsSzpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej 45-061 Opole PolandZurückgezogen» Google-MapsUniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku 60-569 Pozna? PolandAktiv, nicht rekrutierend» Google-MapsInstytut Hematologii i Transfuzjologii; Klinika Hematologii 02-776 Warszawa PolandAktiv, nicht rekrutierend» Google-MapsUniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku 50-367 Wroc?aw PolandAktiv, nicht rekrutierend» Google-MapsPanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center 00935 San Juan Puerto RicoAbgeschlossen» Google-MapsHospital Universitario Marques de Valdecilla; Servicio de Hematologia 39008 Santander SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitari Vall d'Hebron; Servicio de Hematologia 08035 Barcelona SpainAbgeschlossen» Google-MapsHospital Clínic i Provincial; Servicio de Hematología y Oncología 08036 Barcelona SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario la Paz; Servicio de Hematologia 28046 Madrid SpainAbgeschlossen» Google-MapsHospital Universitario Virgen del Rocio; Servicio de Hematologia 41013 Sevilla SpainAktiv, nicht rekrutierend» Google-MapsHospital Clinico Universitario de Valencia; Servicio de Onco-hematologia 46010 Valencia SpainAktiv, nicht rekrutierend» Google-MapsInselspital Bern, Insel-Gruppe AG 3010 Bern SwitzerlandAktiv, nicht rekrutierend» Google-MapsUniversitätsspital Zürich 8091 Zürich SwitzerlandAbgeschlossen» Google-MapsChang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology 833 Kaoisung TaiwanAbgeschlossen» Google-MapsChang Gung Medical Foundation - Linkou; Division of Hematology- Oncology 333 Taoyuan TaiwanAktiv, nicht rekrutierend» Google-MapsTaichung Veterans General Hospital 40705 Xitun Dist. TaiwanAbgeschlossen» Google-MapsBeatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomAktiv, nicht rekrutierend» Google-MapsSt James's Institute of Oncology; Dept of Haematology LS9 7TF Leeds United KingdomAktiv, nicht rekrutierend» Google-MapsUCLH - Clinical Trials Pharmacy B&D Centre N7 9NH London United KingdomAktiv, nicht rekrutierend» Google-MapsChristie Hospital; Department of Haematology and Transplant M20 4BX Manchester United KingdomAbgeschlossen» Google-MapsNottingham City Hospital; Dept of Haematology NG5 1PB Nottingham United KingdomAktiv, nicht rekrutierend» Google-MapsSouthampton General Hospital SO16 6YD Southampton United KingdomZurückgezogen» Google-Maps
1. Overall survival (OS), defined as the time from randomization to date of death from any cause (Time Frame - Up to 5 years)
Secondary outcome:
1. Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC) (Time Frame - Up to 5 years)
2. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator (Time Frame - Up to 5 years)
3. Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC (Time Frame - Up to 5 years)
4. CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator (Time Frame - Up to 5 years)
5. Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC (Time Frame - Up to 5 years)
6. ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator (Time Frame - Up to 5 years)
7. Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first (Time Frame - Up to 5 years)
8. Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first (Time Frame - Up to 5 years)
9. Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) (Time Frame - Up to 5 years)
10. Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS) (Time Frame - Up to 5 years)
11. Percentage of Participants with Adverse Events (Time Frame - Up to 5 years)
12. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events (Time Frame - Up to 5 years)
Experimental: Glofit-GemOx Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.
Experimental: R-GemOx Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.
Obinutuzumab: Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
Glofitamab: Participants will receive IV glofitamab for up to 12 cycles.
Rituxumab: Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Tocilizumab: Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
Gemcitabine: Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Oxaliplatin: Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Quelle: ClinicalTrials.gov
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"A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma"
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