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一项研究，比较 Odronextamab 联合化疗的疗效以及它对既往未经治疗的弥漫性大 B 细胞淋巴瘤患者的利妥昔单抗联合化疗的安全性 (OLYMPIA-3)

2026年11月3日 更新者：Regeneron Pharmaceuticals

一项 3 期、开放标签、随机研究，比较 Odronextamab (REGN1979)（一种抗 CD20 × 抗 CD3 双特异性抗体）联合 CHOP (O-CHOP) 与利妥昔单抗联合 CHOP (R-CHOP) 的疗效和安全性）在先前未经治疗的弥漫性大 B 细胞淋巴瘤 (DLBCL) 参与者中 (OLYMPIA-3)

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study.

This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.

The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug when combined with chemotherapy
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
  • The impact from the study drug on quality of life and ability to complete routine daily activities

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

904

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 以色列
      • Ashdod、以色列、7747629
        • 招聘中
        • Samson Assuta Ashdod University Hospital
      • Haifa、以色列、31048
        • 招聘中
        • Bnai Zion Medical Center
      • Jerusalem、以色列、91200
        • 招聘中
        • Hadassah Medical Center
      • Nahariya、以色列、2210001
        • 招聘中
        • Galilee Medical Center
      • Tel Aviv、以色列、64239
        • 招聘中
        • The Tel Aviv Sourasky Medical Center
    • Tel Aviv
      • Tel HaShomer、Tel Aviv、以色列、5265601
        • 招聘中
        • The Chaim Sheba Medical Center
  • 台湾
      • Changhua、台湾、50006
        • 招聘中
        • Changhua Christian Hospital
      • Kaohsiung City、台湾、80756
        • 招聘中
        • Kaohsiung Medical University Hospital
      • New Taipei City、台湾、23561
        • 招聘中
        • Taipei Medical University - Shuang Ho Hospital
      • Taipei、台湾、11490
        • 招聘中
        • Tri-Service General Hospital
      • Taipei、台湾、00116
        • 招聘中
        • Wanfang Hospital
      • Taipei、台湾、106
        • 招聘中
        • National Taiwan University Hospital
    • Chiayi County
      • Buzi、Chiayi County、台湾、613
        • 招聘中
        • Chang Gung Medical Foundation Chia Yi Branch
    • Hunan Province
      • Taoyuan、Hunan Province、台湾、33305
        • 招聘中
        • Chang Gung Memorial Hospital - Linkou Branch
    • Kaohsiung
      • Niaosong、Kaohsiung、台湾、83301
        • 招聘中
        • Chang Gung Medical Foundation Kaohsiung Branch
  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）、34418
        • 招聘中
        • Istanbul University Istanbul Faculty of Medicine
      • Izmir、土耳其（türkiye）、35340
        • 招聘中
        • Dokuz Eylul University
      • Izmir、土耳其（türkiye）、35100
        • 招聘中
        • Ege University
      • Sakarya、土耳其（türkiye）、54290
        • 招聘中
        • Sakarya University Medical Faculty
      • Samsun、土耳其（türkiye）、55239
        • 招聘中
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
    • Ankara
      • Yenimahalle、Ankara、土耳其（türkiye）、06200
        • 招聘中
        • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
    • Mersin
      • Mezitli、Mersin、土耳其（türkiye）、33200
        • 招聘中
        • VM Medical Park Mersin Hospital
    • Suleymanpasa
      • Tekirdağ、Suleymanpasa、土耳其（türkiye）、59100
        • 招聘中
        • Tekirdag Namik Kemal University Hospital
    • Yenimahalle
      • Ankara、Yenimahalle、土耳其（türkiye）、6500
        • 招聘中
        • Gazi University Faculty of Medicine
  • 奥地利
      • Graz、奥地利、8036
        • 招聘中
        • Medical University Graz
      • Vienna、奥地利、1090
        • 招聘中
        • Medical University of Vienna
      • Vienna、奥地利、1140
        • 招聘中
        • Hanusch Krankenhaus
      • Wels、奥地利、4600
        • 招聘中
        • Klinikum Wels-Grieskirchen
    • Styria
      • Leoben、Styria、奥地利、8700
        • 招聘中
        • Landeskrankenhaus Hochsteiermark
    • Upper Austria
      • Linz、Upper Austria、奥地利、4020
        • 招聘中
        • Kepler University Hospital
  • 巴西
      • Rio de Janeiro、巴西、22793-334
        • 招聘中
        • Instituto Americas
      • Rio de Janeiro、巴西、20231050
        • 招聘中
        • Instituto Nacional de Cancer Jose Alencar Gomes da Silva
      • São Paulo、巴西、01509-010
        • 招聘中
        • AC Camargo Cancer Center
      • São Paulo、巴西、01323-903
        • 招聘中
        • Hospital Alemao Oswaldo Cruz
      • São Paulo、巴西、05403-000
        • 招聘中
        • Clinical Hospital of Medicine School at Sao Paulo University
      • São Paulo、巴西、08270-070
        • 招聘中
        • Casa de Saude Santa Marcelina
      • São Paulo、巴西、05403-010
        • 招聘中
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、41950-640
        • 招聘中
        • Ensino e Terapia de Inovacao Clinica Amo (Etica)
    • Federal District
      • Brasília、Federal District、巴西、70200-730
        • 招聘中
        • Hospital Sirio Libanes Brasilia
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西、30380-472
        • 招聘中
        • Instituto Mario Penna de Ensino Pesquisa e Inovacao
    • Paraná
      • Cascavel、Paraná、巴西、85806-300
        • 招聘中
        • Uopeccan Hospital do Cancer de Cascavel
      • Curitiba、Paraná、巴西、81520-060
        • 招聘中
        • Hospital Erasto Gaertner
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、巴西、59062-000
        • 招聘中
        • Liga Norte Riograndense Contra o Cancer
    • Rio Grande do Sul
      • Bento Gonçalves、Rio Grande do Sul、巴西、95700-084
        • 招聘中
        • Instituto Tacchini de Pesquisa em Saude
      • Porto Alegre、Rio Grande do Sul、巴西、90035-903
        • 招聘中
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre、Rio Grande do Sul、巴西、90110-270
        • 招聘中
        • Centro Gaucho Integrado
    • Santa Catarina
      • Joinville、Santa Catarina、巴西、89201-260
        • 招聘中
        • Centro de Hematologia e Oncologia
      • Lages、Santa Catarina、巴西、88501-001
        • 招聘中
        • Animi Unidade de Tratamento Oncologico Ltda
    • São Paulo
      • Barretos、São Paulo、巴西、14784-400
        • 招聘中
        • Fundacao Pio XII - Hospital de Amor
      • Jaú、São Paulo、巴西、17210-080
        • 招聘中
        • Amaral Carvalho Hospital
  • 德国
      • Berlin、德国、10967
        • 招聘中
        • Vivantes Klinikum Am Urban
      • Dresden、德国、01307
        • 撤销
        • University Hospital Carl Gustav Carus
      • Kiel、德国、24116
        • 撤销
        • Stadtisches Krankenhaus Kiel
    • Baden-Wurttemberg
      • Stuttgart、Baden-Wurttemberg、德国、70376
        • 招聘中
        • Robert-Bosch-Krankenhaus
    • Gmund
      • Mutlangen、Gmund、德国、D-73557
        • 招聘中
        • Kliniken Ostalb Stauferklinikum Schwab Gmund
    • Hesse
      • Frankfurt am Main、Hesse、德国、15236
        • 招聘中
        • Clinic Frankfurt (Oder)
    • North Rhine-Westphalia
      • Essen、North Rhine-Westphalia、德国、45122
        • 招聘中
        • University Hospital Essen
    • Rhineland-Palatinate
      • Mainz、Rhineland-Palatinate、德国、55131
        • 招聘中
        • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
    • Saarland
      • Homburg、Saarland、德国、66421
        • 招聘中
        • UKS Homburg
    • Saxony
      • Dresden、Saxony、德国、01307
        • 招聘中
        • Hematological Praxis Dresden
  • 意大利
      • Milan、意大利、20141
        • 招聘中
        • Istituto Europeo di Oncologia
      • Milan、意大利、20162
        • 招聘中
        • ASST Grande Ospedale Metropolitano Niguarda - Main Address
      • Modena、意大利、41124
        • 招聘中
        • A.O.U. di Modena
      • Naples、意大利、80131
        • 招聘中
        • Federico II University
      • Novara、意大利、28100
        • 招聘中
        • AOU Maggiore della Carita
      • Pavia、意大利、27100
        • 招聘中
        • Fondazione IRCCS Policlinico San Matteo
      • Perugia、意大利、06132
        • 招聘中
        • Azienda Ospedaliera di Perugia
      • Ravenna、意大利、48121
        • 招聘中
        • Ospedale Santa Maria delle Croci
      • Roma、意大利、00128
        • 招聘中
        • Fondazione Policlinico Universitario Campus Bio-Medico
      • Turin、意大利、10126
        • 招聘中
        • Hematology - Città della Salute e della Scienza di Torino
      • Udine、意大利、33100
        • 招聘中
        • Santa Maria della Misericordia
      • Varese、意大利、21100
        • 招聘中
        • Ospedale di Circolo e Fondazione Macchi Varese
    • Forli-Cesena
      • Meldola、Forli-Cesena、意大利、47014
        • 招聘中
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Monza E Brianza
      • Monza、Monza E Brianza、意大利、20900
        • 招聘中
        • ASST Monza Ospedale San Gerardo
    • Piedmont
      • Turin、Piedmont、意大利、10137
        • 招聘中
        • Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
  • 捷克语
      • Prague、捷克语、10034
        • 招聘中
        • University Hospital Kralovske Vinohrady
      • Prague、捷克语、12808
        • 招聘中
        • Vseobecna Fakultni Nemocnice V Praze
    • East Bohemia
      • Hradec Králové、East Bohemia、捷克语、50005
        • 招聘中
        • University Hospital Hradec Kralove
    • South Moravian
      • Brno、South Moravian、捷克语、62500
        • 招聘中
        • University Hospital Brno
  • 新加坡
      • Singapore、新加坡、308433
        • 招聘中
        • Tan Tock Seng Hospital
      • Singapore、新加坡、119074
        • 招聘中
        • National University Hospital Singapore
      • Singapore、新加坡、168583
        • 招聘中
        • National Cancer Centre of Singapore
  • 智利
      • Santiago、智利、7650568
        • 招聘中
        • Clinica Alemana de Santiago
    • Las Condes
      • Santiago、Las Condes、智利、7620157
        • 招聘中
        • Hospital Clinico Universidad de Los Andes
    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利、7560907
        • 招聘中
        • Centro Oncologia de Precision Universidad Mayor
      • Santiago、Santiago Metropolitan、智利、7580206
        • 招聘中
        • Inmunocel
  • 比利时
      • Brussels、比利时、1000
        • 招聘中
        • Institut Jules Bordet
    • Antwerp
      • Herentals、Antwerp、比利时、2200
        • 招聘中
        • AZ St.-Elisabeth Herentals vzw
    • Liege
      • Verviers、Liege、比利时、4800
        • 招聘中
        • Centre Hospitalier Regional de Verviers
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、比利时、9000
        • 招聘中
        • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
    • West-Vlaanderen
      • Roeselare、West-Vlaanderen、比利时、8800
        • 招聘中
        • Algemeen Ziekenhuis AZ Delta
  • 法国
      • Angers、法国、49000
        • 撤销
        • Centre Hospitalier Universitaire Angers
      • Lyon、法国、69008
        • 招聘中
        • Centre Leon Berard
      • Marseille、法国、130005
        • 招聘中
        • Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
      • Metz-Tessy、法国、74374
        • 招聘中
        • Change Annecy
      • Nîmes、法国、30029
        • 招聘中
        • CHU Nimes Institut de Cancerologie
      • Paris、法国、75571
        • 招聘中
        • Assistance Publique-Hopitaux de Paris (AP-HP)
      • Saint-Etienne、法国、42055
        • 招聘中
        • CHU de Saint-Etienne
    • Brittany Region
      • Quimper、Brittany Region、法国、29107
        • 招聘中
        • Centre Hospitalier de Cornouaille Quimper Concarneau
      • Rennes、Brittany Region、法国、35033
        • 招聘中
        • Centre Hospitalier Universitaire (CHU) Rennes
    • Centre-Val de Loire
      • Tours、Centre-Val de Loire、法国、37044
        • 招聘中
        • CHRU de Tours
    • Gironde
      • Bordeaux、Gironde、法国、33077
        • 招聘中
        • Polyclinique Bordeaux Nord Aquitaine
    • New Aquitaine
      • Pessac、New Aquitaine、法国、33600
        • 招聘中
        • Centre Hospitalier Universitaire (CHU) de Bordeaux
      • Poitiers、New Aquitaine、法国、86000
        • 招聘中
        • Centre Hospitalier Universitaire De Poitiers
    • Nord
      • Lille、Nord、法国、5900
        • 招聘中
        • Hopital Saint Vincent-de-Paul
    • Pays de la Loire Region
      • Nantes、Pays de la Loire Region、法国、44093
        • 招聘中
        • Nantes University Hospital
    • Savoie
      • Chambéry、Savoie、法国、73000
        • 招聘中
        • Centre Hospitalier Metropole Savoie
    • Île-de-France Region
      • Argenteuil、Île-de-France Region、法国、95100
        • 招聘中
        • Hopital Victor Dupouy Argenteuil
      • Bobigny、Île-de-France Region、法国、93000
        • 撤销
        • Avicenne Hospital
      • Villejuif、Île-de-France Region、法国、94800
        • 招聘中
        • Gustave Roussy
  • 波兰
      • Bydgoszcz、波兰、85-168
        • 撤销
        • Szpital Uniwersytecki Nr2 Bydgoszcz
      • Gdansk、波兰、80-952
        • 招聘中
        • Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
      • Lublin、波兰、20-954
        • 招聘中
        • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Warsaw、波兰、02-781
        • 招聘中
        • Narodowy Instytut Onkologii
      • Wałbrzych、波兰、58-300
        • 招聘中
        • Szpital Szpecjalistyczny w Walbrzychu
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、30-510
        • 招聘中
        • Matopolskie Centrum Medyczne S.C.
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、50-367
        • 招聘中
        • Uniwersytecki Szpital Kliniczny
    • Wielkopolska
      • Poznan、Wielkopolska、波兰、60185
        • 撤销
        • Pratia Poznan Medical Center
      • Skorzewo、Wielkopolska、波兰、60185
        • 招聘中
        • Aidport Sp. z o.o.
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、93-510
        • 招聘中
        • Wielospecjalistyczne Centrum Onkologii i Traumatologii
  • 泰国
      • Bangkok、泰国、10700
        • 招聘中
        • Sriraj Hospital
      • Chiang Mai、泰国、50200
        • 招聘中
        • Chaing Mai University
      • Khon Kaen、泰国、40002
        • 招聘中
        • Faculty of Medicine
    • Krung Thep Maha Nakhon [Bangko]
      • Bangkok、Krung Thep Maha Nakhon [Bangko]、泰国、10330
        • 招聘中
        • Chulalongkorn University
  • 澳大利亚
    • New South Wales
      • Liverpool、New South Wales、澳大利亚、2170
        • 招聘中
        • Liverpool Hospital
      • Waratah、New South Wales、澳大利亚、2298
        • 招聘中
        • Calvary Mater Newcastle
    • Queensland
      • Auchenflower、Queensland、澳大利亚、4066
        • 招聘中
        • Icon Cancer Centre - Wesley
      • Benowa、Queensland、澳大利亚、4217
        • 招聘中
        • Pindara Private Hospital
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3121
        • 招聘中
        • Epworth Freemasons
  • 爱尔兰
      • Dublin、爱尔兰、D08
        • 撤销
        • St James Hospital and Trinity College Dublin
    • Leinster
      • Dublin、Leinster、爱尔兰、D09V2N0
        • 撤销
        • Beaumont Hospital
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85259
        • 招聘中
        • Mayo Clinic - Arizona
    • California
      • Los Angeles、California、美国、90095
        • 招聘中
        • David Geffen School of Medicine at UCLA
      • Orange、California、美国、92868
        • 招聘中
        • University of California Irvine Medical Center
      • Sacramento、California、美国、95817
        • 撤销
        • UC Davis Comprehensive Cancer Center
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Clinic Jacksonville
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Indianapolis、Indiana、美国、46260
        • 招聘中
        • St Vincent Ascension at Peyton Manning Childrens Hospital
      • Noblesville、Indiana、美国、46062
        • 招聘中
        • Investigative Clinical Research of Indiana
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • 招聘中
        • University of Kentucky
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 招聘中
        • University of Maryland Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Health System
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Cancer and Hematology Centers of Western Michigan
    • Minnesota
      • Rochester、Minnesota、美国、55901
        • 招聘中
        • Mayo Clinic - Rochester
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • 招聘中
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Stony Brook、New York、美国、11794
        • 招聘中
        • Stony Brook University Hospital
      • Westbury、New York、美国、11590
        • 撤销
        • Clinical Research Alliance Inc
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University Medical Center
      • Greenville、North Carolina、美国、27834
        • 招聘中
        • East Carolina University
    • Ohio
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • University Hospitals Cleveland Medical Center
    • Texas
      • Houston、Texas、美国、77030
        • 撤销
        • Center for Oncology and Blood Disorders
    • Utah
      • Ogden、Utah、美国、84405
        • 招聘中
        • Community Cancer Trials of Utah
    • Wisconsin
      • Waukesha、Wisconsin、美国、53188
        • 撤销
        • Prohealth Care Inc
  • 英国
      • Aberdeen、英国、AB25 2ZN
        • 招聘中
        • NHS Grampian: Aberdeen Royal Infirmary
      • Uxbridge、英国、UB8 3NN
        • 招聘中
        • The Hillingdon Hospitals NHS Foundation Trust
  • 西班牙
      • Barcelona、西班牙、08041
        • 招聘中
        • Hospital Sant Pau
      • Barcelona、西班牙、08908
        • 招聘中
        • Institut Catala d'Oncologia
      • Granada、西班牙、18014
        • 招聘中
        • Hospital Virgen De Las Nieves De Granada
      • Madrid、西班牙、28031
        • 招聘中
        • Hospital Universitario Infanta Leonor
      • Madrid、西班牙、28034
        • 招聘中
        • Hospital Universitario Ramon y Cajal
      • Madrid、西班牙、28050
        • 招聘中
        • Hospital Universitario HM Sanchinarro
      • Madrid、西班牙、28040
        • 招聘中
        • Fundacion Jimenez Diaz University Hospital
      • Seville、西班牙、41009
        • 招聘中
        • Hospital Universitario Virgen Macarena
      • Toledo、西班牙、45007
        • 撤销
        • Hospital General Universitario de Toledo
      • Valencia、西班牙、46026
        • 招聘中
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
      • Valencia、西班牙、46017
        • 招聘中
        • University Hospital Doctor Peset
      • Valencia、西班牙、46009
        • 招聘中
        • Instituto Valenciano de Oncologia
    • A Coruna
      • Santiago de Compostela、A Coruna、西班牙、15706
        • 招聘中
        • Hospital Clinico Universitario Santiago de Compostela
    • Andalusia
      • Seville、Andalusia、西班牙、41013
        • 招聘中
        • Hospital Universitario Virgen del Rocio
    • Balearic Islands
      • Palma、Balearic Islands、西班牙、07120
        • 招聘中
        • Son Espases University Hospital
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • 招聘中
        • Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
      • Sabadell、Barcelona、西班牙、08208
        • 招聘中
        • Hospital Universitari Parc Tauli
      • Terrassa、Barcelona、西班牙、08221
        • 招聘中
        • Hospital Universitari Mutua Terrassa
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • 招聘中
        • Hospital Universitario Marques de Valdecilla
    • Galicia
      • A Coruña、Galicia、西班牙、15006
        • 招聘中
        • Complejo Hospitalario Universitario de a Coruna
    • Madrid
      • Pozuelo de Alarcón、Madrid、西班牙、28223
        • 招聘中
        • Hospital Universitario Quironsalud Madrid
    • Navarre
      • Pamplona、Navarre、西班牙、31008
        • 招聘中
        • Hospital Universitario de Navarra
    • Principality of Asturias
      • Oviedo、Principality of Asturias、西班牙、33011
        • 招聘中
        • Hospital Universitario Central de Asturias
  • 韩国
      • Busan、韩国、49241
        • 招聘中
        • Pusan National University Hospital
      • Busan、韩国、47392
        • 招聘中
        • Inje University Busan Paik Hospital
      • Busan、韩国、49201
        • 招聘中
        • Dong-A University Hospital
      • Daegu、韩国、42601
        • 招聘中
        • Keimyung University Dongsan Hospital
      • Daegu、韩国、42415
        • 招聘中
        • Yeyungnam University Medical Center
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
      • Seoul、韩国、07345
        • 招聘中
        • Yeouido St. Marys Hospital
      • Seoul、韩国、137-701
        • 招聘中
        • Seoul St Marys Hospital
    • Gyeonggi-do
      • Suwon、Gyeonggi-do、韩国、16247
        • 招聘中
        • St. Vincent Hospital - The Catholic University of Korea
    • Namdong-Gu
      • Incheon、Namdong-Gu、韩国、21565
        • 招聘中
        • Gachon University Gil Medical Center
  • 马来西亚
    • Kuala Lumpur
      • Kuala Lumpur、Kuala Lumpur、马来西亚、59100
        • 招聘中
        • University Malaya Medical Centre
    • Pahang
      • Kuantan、Pahang、马来西亚、25200
        • 招聘中
        • Hospital Tg Ampuan Afzan
    • Sabah
      • Kota Kinabalu、Sabah、马来西亚、88200
        • 招聘中
        • Hospital Queen Elizabeth
    • Selangor
      • Ampang、Selangor、马来西亚、68000
        • 招聘中
        • Hospital Ampang
      • Subang Jaya、Selangor、马来西亚、47500
        • 招聘中
        • Subang Jaya Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)
  2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  4. Life expectancy ≥ 12 months
  5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
  6. Adequate hematologic and organ function, as defined in the protocol.

Key Exclusion Criteria:

  1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
  2. Another active malignancy, significant active disease or medical condition, as described in the protocol
  3. Peripheral neuropathy Grade ≥3
  4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.
  5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
  6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
  7. Allergy/hypersensitivity to study drugs, as described in the protocol
  8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Odronextamab + CHOP

Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).
药品：Odronextamab

Odronextamab will be administered by intravenous (IV) infusion

其他名称：
  • REGN1979
  • Ordspono™
药品：Cyclophosphamide

Cyclophosphamide will be administered IV as part of chemotherapy

其他名称：
  • Cytoxan®
药品：Doxorubicin

Doxorubicin will be administered IV as part of chemotherapy

其他名称：
  • 阿霉素®
药品：Vincristine

Vincristine will be administered IV as part of chemotherapy

其他名称：
  • Oncovin®
  • Vincasar PFS®
药品：Prednisone/Prednisolone

Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

其他名称：
  • Deltasone®/OMNIPRED®
有源比较器：Rituximab + CHOP

Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.
药品：Cyclophosphamide

Cyclophosphamide will be administered IV as part of chemotherapy

其他名称：
  • Cytoxan®
药品：Doxorubicin

Doxorubicin will be administered IV as part of chemotherapy

其他名称：
  • 阿霉素®
药品：Vincristine

Vincristine will be administered IV as part of chemotherapy

其他名称：
  • Oncovin®
  • Vincasar PFS®
药品：Prednisone/Prednisolone

Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

其他名称：
  • Deltasone®/OMNIPRED®
药品：Rituximab

Rituximab will be administered IV, or subcutaneously (SC)

其他名称：
  • 美罗华®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Dose Limiting Toxicities (DLTs)
大体时间：Up to 35 days

Part 1A
Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
大体时间：Up to 2 years

Part 1
Up to 2 years
Severity of TEAEs
大体时间：Up to 2 years

Part 1
Up to 2 years
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
大体时间：Up to 5 years

Part 2
Up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to 5 years

Part 2
Up to 5 years
Incidence of TEAEs
大体时间：Up to 2 years

Part 2
Up to 2 years
Severity of TEAEs
大体时间：Up to 2 years

Part 2
Up to 2 years
Event-Free Survival (EFS) assessed by ICR
大体时间：Up to 5 years

Part 2
Up to 5 years
Complete Response (CR) assessed by ICR
大体时间：Up to 22 weeks

Part 2
Up to 22 weeks
Best Overall Response (BOR) as assessed by local investigators
大体时间：Up to 22 weeks

Part 1 and Part 2
Up to 22 weeks
CR as assessed by local investigators
大体时间：Up to 22 weeks

Part 1 and Part 2
Up to 22 weeks
Duration of Response (DOR) as assessed by local investigators
大体时间：Up to 5 years

Part 1 and Part 2
Up to 5 years
Odronextamab concentrations in serum when administered with CHOP
大体时间：Up to 22 weeks

Part 1 and Part 2
Up to 22 weeks
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
大体时间：Up to 22 weeks

Part 1 and Part 2
Up to 22 weeks
Magnitude of ADA to odronextamab
大体时间：Up to 22 weeks

Part 1 and Part 2
Up to 22 weeks
PFS assessed by local investigator review
大体时间：Up to 5 years

Part 2
Up to 5 years
EFS assessed by local investigator review
大体时间：Up to 5 years

Part 2
Up to 5 years
BOR assessed by ICR
大体时间：Up to 22 weeks

Part 2
Up to 22 weeks
DOR assessed by ICR
大体时间：Up to 5 years

Part 2
Up to 5 years
Minimal Residual Disease (MRD) status
大体时间：Up to 22 weeks

Part 2
Up to 22 weeks
Change in physical functioning as measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C) 30
大体时间：Up to 5 years

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
Up to 5 years
Change in patient reported outcomes, as measured by EORTC QLQ-C30
大体时间：Up to 5 years

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
Up to 5 years
Change in patient reported outcomes, as measured by Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS)
大体时间：Up to 5 years

Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.
Up to 5 years
Change in patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS)
大体时间：Up to 5 years

Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).
Up to 5 years
Change in patient reported outcomes, as measured by Patient Global Impression of Change (PGIC)
大体时间：Up to 5 years

Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.
Up to 5 years
Change in patient reported outcomes, as measured by EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
大体时间：Up to 5 years

Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
Up to 5 years
Change in score of the Functional Assessment of Cancer Therapy-General (FACT-G ) GP5 item
大体时间：Up to 5 years

Part 2 A single item (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年12月13日

初级完成 (估计的)

2028年3月30日

研究完成 (估计的)

2029年9月12日

研究注册日期

首次提交

2023年10月13日

首先提交符合 QC 标准的

2023年10月13日

首次发布 (实际的)

2023年10月19日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R1979-ONC-2105
  • 2022-502785-25-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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