여포성 림프종 참가자를 위한 Odronextamab이 안전하고 내약성이 좋은지, 그리고 다양한 유형의 화학요법과 결합된 Rituximab과 비교하여 얼마나 잘 작동하는지 알아보기 위한 시험 (OLYMPIA-1)
이전에 치료받지 않은 여포성 림프종 참가자(OLYMPIA-1)를 대상으로 항-CD20 X 항-CD3 이중특이적 항체인 Odronextamab(REGN1979)의 효능과 안전성을 연구자의 선택과 비교하기 위한 제3상 공개 라벨 무작위 연구
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.
The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). 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
- 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)
- How the study drug affects quality of life and ability to complete routine daily activities.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Administrator
- 전화번호: 844-734-6643
- 이메일: clinicaltrials@regeneron.com
연구 장소
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-
-
Changhua, 대만, 500-06
- 모병
- Changhua Christian Hospital
-
Kaohsiung City, 대만, 83301
- 모병
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City, 대만, 80756
- 모병
- Chung-Ho Memorial Hospital
-
New Taipei City, 대만, 235
- 모병
- Taipei Medical University-Shuang Ho Hospital
-
Taichung, 대만, 40705
- 모병
- Taichung General Veterans Hospital
-
Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital
-
Taipei, 대만, 114
- 모병
- Tri-Service General Hospital
-
Taipei, 대만, 11217
- 완전한
- Taipei Veterans General Hospital
-
Taipei, 대만, 100225
- 모병
- National Taiwan University Hospital
-
Taipei, 대만, 116
- 모병
- Taipei Municipal Wan Fang Hospital
-
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Chiayi County
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Buzi, Chiayi County, 대만, 613
- 빼는
- Chang Gung Medical Foundation Chia Yi Branch
-
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Guishan District
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Taoyuan City, Guishan District, 대만, 333
- 모병
- Chang Gung Memorial Hospital Linkou
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-
-
-
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Busan, 대한민국, 49241
- 모병
- Pusan National University Hospital
-
Busan, 대한민국, 49201
- 완전한
- Dong-A University Hospital
-
Daegu, 대한민국, 41404
- 빼는
- Kyungpook National University Chilgok Hospital
-
Seoul, 대한민국, 06591
- 빼는
- Seoul St. Mary's Hospital
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, 대한민국, 10408
- 빼는
- Center for Hematologic Malignancy
-
Suwon, Gyeonggi-do, 대한민국, 16499
- 모병
- Ajou University Hospital
-
Suwon, Gyeonggi-do, 대한민국, 16247
- 모병
- St. Vincents Hospital - The Catholic University of Korea
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, 대한민국, 54907
- 빼는
- Jeonbuk National University Hospital
-
-
-
-
-
Berlin, 독일, 12203
- 모병
- Charite Universitatsmedizin Berlin Campus Benjamin Franklin
-
Dresden, 독일, 01307
- 모병
- University Hospital Carl Gustav Carus
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Kiel, 독일, 24116
- 모병
- Stadtisches Krankenhaus Kiel
-
-
Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, 독일, 70376
- 빼는
- Robert-Bosch-Krankenhaus
-
-
Bavaria
-
Würzburg, Bavaria, 독일, 97080
- 모병
- University Hospital Wurzburg
-
-
Gmund
-
Mutlangen, Gmund, 독일, D-73557
- 모병
- Kliniken Ostalb Stauferklinikum Schwab Gmund
-
-
Hesse
-
Frankfurt am Main, Hesse, 독일, 15236
- 빼는
- Clinic Frankfurt (Oder)
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, 독일, 55131
- 모병
- Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
-
-
Saxony
-
Dresden, Saxony, 독일, 01307
- 모병
- Hematological Praxis Dresden
-
-
-
-
Arizona
-
Tucson, Arizona, 미국, 85724
- 모병
- University of Arizona Cancer Center
-
-
California
-
Los Angeles, California, 미국, 90095
- 모병
- David Geffen School of Medicine at UCLA
-
Orange, California, 미국, 92868
- 빼는
- UC Irvine Health
-
-
Indiana
-
Noblesville, Indiana, 미국, 46062
- 모병
- Investigative Clinical Research of Indiana
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- 모병
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Detroit, Michigan, 미국, 48201
- 모병
- Karmanos Cancer Institute
-
-
Mississippi
-
Hattiesburg, Mississippi, 미국, 39401
- 완전한
- Hattiesburg Clinic
-
-
New York
-
New York, New York, 미국, 10029
- 모병
- Icahn School of Medicine at Mt Sinai
-
Stony Brook, New York, 미국, 11794
- 모병
- Stony Brook University Hospital
-
Westbury, New York, 미국, 11590
- 빼는
- Clinical Research Alliance Inc
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27514
- 모병
- University of North Carolina
-
Charlotte, North Carolina, 미국, 28207
- 모병
- Levine Cancer Institute
-
-
Ohio
-
Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbilt University Medical Center
-
-
Texas
-
Houston, Texas, 미국, 77030
- 모병
- Center for Oncology and Blood Disorders
-
Tyler, Texas, 미국, 75701
- 빼는
- HOPE Cancer Center of East Texas
-
-
Utah
-
Salt Lake City, Utah, 미국, 84112
- 모병
- Huntsman Cancer Institute - Oncology Division
-
-
Virginia
-
Charlottesville, Virginia, 미국, 22908
- 모병
- University of Virginia
-
Richmond, Virginia, 미국, 23219
- 빼는
- Virginia Commonwealth University
-
-
Wisconsin
-
Waukesha, Wisconsin, 미국, 53188
- 빼는
- Prohealth Care Inc
-
-
-
-
-
Antwerp, 벨기에, 2060
- 빼는
- Ziekenhuis Netwerk Antwerpen Stuivenberg
-
Brussels, 벨기에, 1000
- 빼는
- Institut Jules Bordet
-
-
Antwerp
-
Herentals, Antwerp, 벨기에, 2200
- 빼는
- AZ St.-Elisabeth Herentals vzw
-
-
Hainaut
-
La Louvière, Hainaut, 벨기에, 7100
- 빼는
- Hopital De Jolimont
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, 벨기에, 9000
- 빼는
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
-
-
-
-
-
Brasília, 브라질, 70390-140
- 모병
- Instituto DOr de Pesquisa e Ensino Df Star
-
Rio de Janeiro, 브라질, 22793-334
- 모병
- Instituto Americas
-
Rio de Janeiro, 브라질, 20231050
- 빼는
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
-
São Paulo, 브라질, 01323-903
- 모병
- Hospital Alemao Oswaldo Cruz
-
São Paulo, 브라질, 01509010
- 모병
- AC Camargo Cancer Center
-
São Paulo, 브라질, 05403-000
- 모병
- Clinical Hospital of Medicine School at Sao Paulo University
-
São Paulo, 브라질, 08270-070
- 모병
- Casa de Saude Santa Marcelina
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, 브라질, 41950640
- 모병
- Ensino e Terapia de Inovacao Clinica Amo (Etica)
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, 브라질, 30380-420
- 모병
- Instituto Mario Pena de Ensino Pesquisa e Inovacao
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, 브라질, 59062-000
- 모병
- Liga Norte Riograndense Contra o Cancer
-
-
Rio Grande do Sul
-
Passo Fundo, Rio Grande do Sul, 브라질, 99010-080
- 모병
- Instituto do Cancer em Hospital Sao Vicente de Paulo
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
- 모병
- Hospital de Clinicas de Porto Alegre
-
-
Santa Catarina
-
Joinville, Santa Catarina, 브라질, 89201260
- 모병
- Centro de Hematologia e Oncologia
-
Lages, Santa Catarina, 브라질, 88501-001
- 모병
- Animi Unidade de Tratamento Oncologico Ltda
-
-
São Paulo
-
Barretos, São Paulo, 브라질, 14784-400
- 모병
- Fundacao Pio XII Hospital de Amor
-
Jaú, São Paulo, 브라질, 17210080
- 모병
- Amaral Carvalho Hospital
-
Ribeirão Preto, São Paulo, 브라질, 14048-900
- 모병
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
-
-
-
-
-
Basel, 스위스, 4031
- 모병
- University Hospital Basel
-
Bern, 스위스, 3010
- 모병
- Inselspital Bern University Hospital
-
-
Canton of Aargau
-
Baden, Canton of Aargau, 스위스, 5404
- 모병
- Kantonsspital Baden
-
-
Canton of St. Gallen
-
Sankt Gallen, Canton of St. Gallen, 스위스, 9007
- 모병
- Cantonal Hospital St Gallen
-
-
Schweiz
-
Winterthur, Schweiz, 스위스, 8401
- 모병
- Kantonsspital Winterthur Medical Oncology
-
-
-
-
-
Barcelona, 스페인, 08035
- 모병
- University Hospital Vall d'Hebron
-
Barcelona, 스페인, 08041
- 모병
- Hospital de la Santa Creu i Sant Pau
-
Granada, 스페인, 18014
- 모병
- Hospital Virgen De Las Nieves De Granada
-
Madrid, 스페인, 28027
- 모병
- Clinica Universidad de Navarra
-
Madrid, 스페인, 28027
- 빼는
- Clinica Universidad de Navarra
-
Madrid, 스페인, 28040
- 모병
- Fundacion Jimenez Diaz University Hospital
-
Madrid, 스페인, 28041
- 모병
- University Hospital & Research Institute
-
Madrid, 스페인, 28050
- 모병
- Hospital Universitario HM Sanchinarro, Servicio de Hematologia
-
Madrid, 스페인, 28007
- 모병
- Gregorio Maranon
-
Murcia, 스페인, 30008
- 모병
- Morales Meseguer Hospital
-
Ourense, 스페인, 32005
- 빼는
- Complexo Hospitalario Universitario de Ourense
-
Salamanca, 스페인, 37007
- 모병
- Hospital Universitario de Salamanca
-
Seville, 스페인, 41014
- 모병
- Hospital Universitario Virgen de Valme
-
Seville, 스페인, 41013
- 모병
- University Hospital Virgen del Rocio
-
Toledo, 스페인, 45007
- 빼는
- Hospital General Universitario de Toledo
-
Valencia, 스페인, 46026
- 모병
- Hospital Universitari and Politecnic La Fe
-
Valencia, 스페인, 46010
- 빼는
- Hospital Clinico Universitario Valencia
-
Zaragoza, 스페인, 50009
- 모병
- Hospital Clinico Lozano Blesa
-
-
A Coruna
-
Santiago de Compostela, A Coruna, 스페인, 15706
- 모병
- University Hospital of Santiago de Compostela
-
-
Andalusia
-
Málaga, Andalusia, 스페인, 29010
- 모병
- Hospital Universitario Virgen De La Victoria Malaga
-
Seville, Andalusia, 스페인, 41009
- 모병
- Hospital Universitario Virgen Macarena
-
-
Balearic Islands
-
Palma, Balearic Islands, 스페인, 07120
- 빼는
- Son Espases University Hospital
-
-
Bizkaia
-
Barakaldo, Bizkaia, 스페인, 48903
- 모병
- Cruces University Hospital (Hospital Universitario Cruces)
-
-
Cantabria
-
Santander, Cantabria, 스페인, 39008
- 모병
- Hospital Universitario Marques de Valdecilla
-
-
Galicia
-
A Coruña, Galicia, 스페인, 15006
- 빼는
- Complejo Hospitalario Universitario de a Coruna
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, 스페인, 28223
- 모병
- Hospital Universitario Quironsalud Madrid
-
-
Murcia
-
El Palmar, Murcia, 스페인, 30120
- 빼는
- Hospital Clinico Universitario Virgen De La Arrixaca
-
-
Navarre
-
Pamplona, Navarre, 스페인, 31008
- 모병
- Hospital Universitario de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, 스페인, 33011
- 빼는
- Hospital Universitario Central de Asturias
-
-
-
-
-
Romford, 영국, RM7 0AG
- 모병
- Barking, Havering and Redbridge University Hospitals NHS Trust
-
-
Cornwall
-
Truro, Cornwall, 영국, TR1 3LJ
- 모병
- Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
-
-
Devon
-
Plymouth, Devon, 영국, PL6 8DH
- 빼는
- Derriford Hospital and the Royal Eye Infirmary
-
-
Dorset
-
Bournemouth, Dorset, 영국, BH77DW
- 모병
- University Hospitals Dorset
-
-
Lanarkshire
-
Glasgow, Lanarkshire, 영국, G12 0YN
- 모병
- Beatson West of Scotland Cancer Centre
-
-
Norfolk
-
Norwich, Norfolk, 영국, NR4 7UY
- 모병
- Norfolk and Norwich University Hospital
-
-
-
-
-
Linz, 오스트리아, 4020
- 모병
- Ordensklinikum Linz Gmbh, Elisabethinen
-
Salzburg, 오스트리아, 5020
- 모병
- Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
-
Vienna, 오스트리아, 1090
- 모병
- Medical University of Vienna
-
Vienna, 오스트리아, 1140
- 모병
- Hanusch Krankenhaus
-
-
Osterreich
-
Linz, Osterreich, 오스트리아, 4010
- 모병
- Ordensklinikum Linz
-
-
-
-
-
Ashdod, 이스라엘, 7747629
- 모병
- Samson Assuta Ashdod University Hospital
-
Haifa, 이스라엘, 31048
- 모병
- Bnai Zion Medical Center
-
Jerusalem, 이스라엘, 91200
- 모병
- Hadassah Medical Center
-
Nahariya, 이스라엘, 2210001
- 모병
- Galilee Medical Center
-
Petah Tikva, 이스라엘, 4941492
- 모병
- Rabin Medical Center
-
Ramat Gan, 이스라엘, 5265601
- 모병
- Chaim Sheba Medical Center
-
Tel Aviv, 이스라엘, 64239
- 모병
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Ascoli Piceno, 이탈리아, 63100
- 빼는
- UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
-
Bologna, 이탈리아, 40138
- 빼는
- Irccs Aou Di Bologna - Policlinico Di Sant'orsola Malpighi
-
Brescia, 이탈리아, 25123
- 모병
- Azienda Ospedaliera Spedali Civili di Brescia
-
Milan, 이탈리아, 20141
- 모병
- Istituto Europeo di Oncologia
-
Naples, 이탈리아, 80131
- 완전한
- Federico II University
-
Novara, 이탈리아, 28100
- 모병
- AOU Maggiore della Carita-SCDU Ematologia
-
Ravenna, 이탈리아, 48121
- 모병
- UO Ematologia Ravenna
-
Udine, 이탈리아, 33100
- 모병
- Santa Maria della Misericordia
-
Varese, 이탈리아, 21100
- 모병
- Ospedale dell'Angelo - Varese
-
-
Forli Cesena
-
Meldola, Forli Cesena, 이탈리아, 47014
- 모병
- Istituto Romagnolo Per Lo Studio Dei Tumori
-
-
Lecce
-
Tricase, Lecce, 이탈리아, 73039
- 모병
- Pia Fondazione Panico
-
-
Liguria
-
Genoa, Liguria, 이탈리아, 16132
- 모병
- IRCCS Ospedale Policlinico San Martino
-
-
Torino
-
Candiolo, Torino, 이탈리아, 10060
- 모병
- Candiolo Cancer Institute, FPO, IRCCS
-
-
-
-
-
Hradec Králové, 체코, 50005
- 모병
- University Hospital Hradec Kralove
-
Prague, 체코, 10034
- 모병
- University Hospital Kralovske Vinohrady
-
Prague, 체코, 12808
- 모병
- Vseobecna Fakultni Nemocnice
-
-
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, 칠레, 7500921
- 모병
- Fundacion Arturo Lopez Perez
-
Santiago, Santiago Metropolitan, 칠레, 7580206
- 모병
- Inmunocel
-
Santiago, Santiago Metropolitan, 칠레, 7650620
- 모병
- Clinica Alemana de Santiago
-
Santiago, Santiago Metropolitan, 칠레, 7560907
- 빼는
- Centro Oncologia de Precision Universidad Mayor
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 4J8
- 모병
- Tom Baker Cancer Center
-
-
New Brunswick
-
Saint John, New Brunswick, 캐나다, E2L 4L2
- 모병
- Saint John Regional Hospital
-
-
Quebec
-
Greenfield Park, Quebec, 캐나다, J4V 2H1
- 모병
- Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
-
Québec, Quebec, 캐나다, G1J1Z4
- 모병
- CHU de Quebec - Universite Laval
-
Sherbrooke, Quebec, 캐나다, J1H 5N4
- 모병
- Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
-
-
-
-
-
Ankara, 터키 (Türkiye), 06100
- 빼는
- Liv Hospital Ankara
-
Istanbul, 터키 (Türkiye), 34365
- 모병
- VKV American Hopital
-
Istanbul, 터키 (Türkiye), 34418
- 모병
- Istanbul University Istanbul Faculty of Medicine
-
Izmir, 터키 (Türkiye), 35100
- 모병
- Ege University
-
Kayseri, 터키 (Türkiye), 38039
- 모병
- Erci̇yes Uni̇versi̇ty
-
Sakarya, 터키 (Türkiye), 54290
- 모병
- Sakarya University Medical Faculty
-
Samsun, 터키 (Türkiye), 55239
- 빼는
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
Zonguldak, 터키 (Türkiye), 67100
- 빼는
- Zonguldak Bulent Ecevit University
-
-
Ankara
-
Mamak, Ankara, 터키 (Türkiye), 06620
- 빼는
- Ankara University Faculty of Medicine
-
Yenimahalle, Ankara, 터키 (Türkiye), 06200
- 모병
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
-
Central Anatolia
-
Ankara, Central Anatolia, 터키 (Türkiye), 06100
- 모병
- Gazi University
-
-
Mersin
-
Mezitli, Mersin, 터키 (Türkiye), 33200
- 빼는
- VM Medical Park Mersin Hospital
-
-
Suleymanpasa
-
Tekirdağ, Suleymanpasa, 터키 (Türkiye), 59100
- 모병
- Tekirdag Namik Kemal University Hospital
-
-
-
-
-
Katowice, 폴란드, 40-519
- 모병
- Pratia Onkologia Katowice
-
Lodz, 폴란드, 93-513
- 빼는
- Copernicus Memorial Hospital
-
Lublin, 폴란드, 20-954
- 모병
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
-
Warsaw, 폴란드, 02781
- 빼는
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
-
-
Lower Silesian Voivodeship
-
Wałbrzych, Lower Silesian Voivodeship, 폴란드, 58-309
- 모병
- Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
-
Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-367
- 모병
- Uniwersytecki Szpital Kliniczny
-
-
Malopolska
-
Krakow, Malopolska, 폴란드, 30-510
- 모병
- Pratia MCM Krakow
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, 폴란드, 80-952
- 모병
- Uniwersyteckie Centrum Kliniczne
-
-
Wielkopolska
-
Skorzewo, Wielkopolska, 폴란드, 60185
- 완전한
- Cm Pratia Poznan
-
Skorzewo, Wielkopolska, 폴란드, 60185
- 모병
- Aidport Sp. z o.o.
-
-
-
-
-
Angers, 프랑스, 49933
- 모병
- Centre Hospitalier Universitaire Angers
-
Marseille, 프랑스, 13009
- 모병
- Institut Paoli Calmettes
-
Paris, 프랑스, 75010
- 모병
- Hopital Saint Louis
-
Paris, 프랑스, 755710
- 모병
- Hopital Saint-Antoine
-
Strasbourg, 프랑스, 67033
- 모병
- Institut de Cancerologie Strasbourg Europe (ICANS)
-
-
Brittany Region
-
Rennes, Brittany Region, 프랑스, 35033
- 모병
- Centre Hospitalier Universitaire (CHU) Rennes
-
-
Centre-Val de Loire
-
Tours, Centre-Val de Loire, 프랑스, 37044
- 모병
- Centre Hospitalier Regional Universitaire de Tours
-
-
Pays de la Loire Region
-
Nantes, Pays de la Loire Region, 프랑스, 44093
- 빼는
- Nantes University Hospital
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille, Provence-Alpes-Côte d'Azur Region, 프랑스, 13005
- 모병
- Hopital de la Conception
-
-
Vienne
-
Poitiers, Vienne, 프랑스, 86021
- 빼는
- Centre Hospitalier Universitaire (CHU) de Poitiers
-
-
Île-de-France Region
-
Argenteuil, Île-de-France Region, 프랑스, 95100
- 모병
- Hopital Victor Dupouy Argenteuil
-
Villejuif, Île-de-France Region, 프랑스, 94800
- 모병
- Gustave Roussy
-
-
-
-
New South Wales
-
Liverpool, New South Wales, 호주, 2170
- 모병
- Ingham Institute
-
-
Queensland
-
Auchenflower, Queensland, 호주, 4066
- 완전한
- Icon Cancer Centre - Wesley
-
-
South Australia
-
Bedford Park, South Australia, 호주, 5042
- 모병
- Flinders Medical Centre
-
-
Victoria
-
Clayton, Victoria, 호주, 3168
- 모병
- Monash Health
-
East Melbourne, Victoria, 호주, 3121
- 모병
- Epworth Freemasons
-
Melbourne, Victoria, 호주, 3065
- 모병
- St Vincents Hospital Melbourne
-
Melbourne, Victoria, 호주, 3004
- 모병
- Alfred Hospital and Monash University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
- Need for treatment as described in the protocol
- Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow function and hepatic function, as described in the protocol
Key Exclusion Criteria:
- Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
- Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- Treatment with any systemic anti-lymphoma therapy
- Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Odronextamab
Part 1 is a safety run-in. All participants will receive odronextamab. In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance. |
Administered per the protocol
다른 이름들:
|
|
활성 비교기: Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance. |
Administered per the protocol
다른 이름들:
Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
다른 이름들:
Administered per the protocol as part of CHOP chemotherapy
다른 이름들:
Administered per the protocol as part of CHOP, and CVP chemotherapy
다른 이름들:
Administered per the protocol as part of CVP chemotherapy
다른 이름들:
Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
기간: Up to 35 days
|
Part 1 |
Up to 35 days
|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
기간: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Severity of TEAEs of odronextamab
기간: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Complete Response at 30 months (CR30) as assessed by independent central review
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Concentrations of odronextamab in serum
기간: Up to 30 months
|
Part 1 |
Up to 30 months
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab
기간: Up to 30 months
|
Part 1 |
Up to 30 months
|
|
Magnitude of ADAs to odronextamab
기간: Up to 30 months
|
Part 1 |
Up to 30 months
|
|
Objective response as assessed by the investigator
기간: Up to 30 months
|
Part 1 |
Up to 30 months
|
|
Progression-Free Survival (PFS) as assessed by independent central review
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Event-Free Survival (EFS) as assessed by independent central review
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Overall Survival (OS)
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
기간: 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 global health status (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
|
|
CR30 as assessed by local investigator
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
PFS as assessed by the local investigator
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS as assessed by the local investigator
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Objective response assessed by local investigator
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Objective response assessed by independent central review
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Duration Of Response (DOR) assessed by independent central review
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
DOR assessed by local investigator
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Time To Next anti-lymphoma Treatment (TTNT)
기간: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Incidence of TEAEs
기간: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
기간: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Odronextamab concentrations in serum during the induction period
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Odronextamab concentrations in serum during the maintenance period
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Occurrence of ADAs to odronextamab
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Magnitude of ADAs to odronextamab
기간: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
기간: 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 global health status (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
|
|
Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
기간: 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
|
|
Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
기간: 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 Patient Global Impression of Severity (PGIS)
기간: 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 Global Impression of Change (PGIC)
기간: 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 score of the GP5 item in the participant population
기간: Up to 5 years
|
Part 2 A single item Global Population item 5 (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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 림프계 질환
- 림프 증식 장애
- 면역증식성 장애
- 림프종, 비호지킨
- 림프종
- 헴 및 림프병
- 림프종, 여포성
- 아미노산, 펩티드 및 단백질
- 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물
- Benzimidazoles
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 탄화수소
- 탄화수소, 순환
- 탄수화물
- 산, acyclic
- 카르 복실 산
- 알칼로이드
- 다 환식 방향족 탄화수소
- 탄화수소, 방향족
- 다 환식 화합물
- 글리코 사이드
- 인돌
- 항체, 모노클로 날
- 항체
- 면역 글로불린
- 면역 단백질
- 혈액 단백질
- 혈청 글로불린
- 글로불린
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 포스 포 아미드 머스타드
- 질소 머스타드 화합물
- 겨자 화합물
- 탄화수소, 할로겐화
- 포스 포 아미드
- 유기 인 화합물
- Pregnadienetriols
- Pregnadienediols
- Vinca 알칼로이드
- Secologanin Tryptamine 알칼로이드
- 인돌 알칼로이드
- 인돌리 지딘
- 인도인
- 안트라 사이클린
- 나프 타센
- 아미노 글리코 시드
- 부티레이트
- 항체, 모노클로 날, 뮤린 유래
- Daunorubicin
- 벤다무스틴 염산염
- 리툭시맙
- 프레드니손
- 프레드니솔론
- 시클로포스파미드
- 독소루비신
- 빈크리스틴
- 메틸프레드니솔론
기타 연구 ID 번호
- R1979-HM-2298
- 2022-502660-20-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .