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ACTIVE NOT RECRUITING
NCT04384484
PHASE3

Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Sponsor: ADC Therapeutics S.A.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

Official title: A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2020-09-16

Completion Date

2028-06-30

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Loncastuximab Tesirine

Intravenous Infusion

DRUG

Rituximab

Intravenous Infusion

DRUG

Gemcitabine

Intravenous Infusion

DRUG

Oxaliplatin

Intravenous Infusion

Locations (144)

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Redlands Community Hospital

Redlands, California, United States

The Oncology Institute of Hope and Innovation

Whittier, California, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

UnityPoint Health - Iowa Oncology Research Association (IORA)

Des Moines, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Comprehensive Cancer Centers of Nevada - Henderson

Las Vegas, Nevada, United States

Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, United States

Hollings Cancer Center

Charleston, South Carolina, United States

Virginia Cancer Specialists

Gainesville, Virginia, United States

Medical College of Wisconsin Cancer Center Clinical Trials Office

Milwaukee, Wisconsin, United States

Clinica Adventista Belgrano

Belgrano, Buenos Aires, Argentina

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares S.A.

Santa Fe, Buenos Aires, Argentina

Instituto Médico Especializado Alexander Fleming

Buenos Aires, Distrito Federal, Argentina

Grupo Gamma - Hospital Privado Rosario

Rosario, Santa Fe Province, Argentina

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Hospitalier Universitaire Universite Catholique de Louvain

Namur, Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, Belgium

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Paraná, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mãe de Deus - Centro Integrado de Oncologia

Porto Alegre, Rio Grande do Sul, Brazil

Hospital do Câncer

Rio de Janeiro, Brazil

Hemomed Instituto de Oncologia e Hematologia

São Paulo, Brazil

A Beneficência Portuguesa de São Paulo - Unidade Mirante

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Canada

Research Institute of the McGill University Health Centre

Montreal, Canada

Hôpital Fleurimont

Sherbrooke, Canada

Centro de Estudios Clínicos SAGA

Santiago, Santiago Metropolitan, Chile

Instituto Oncológico Fundación Arturo López Pérez

Santiago, Santiago Metropolitan, Chile

CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

Santiago, Santiago Metropolitan, Chile

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital - Zhengzhou University

Zhengzhou, Henan, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China School of Medicine - West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Chongqing University Cancer Hospital - Chongqing Cancer Hospital

Chongqing, China

Huizhou Municipal Central Hospital

Huizhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC

Tianjin, China

Wuhan Union Hospital

Wuhan, China

Tongji Hospital

Wuhan, China

Fakultni nemocnice Ostrava

Ostrava, Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Centre Hospitalier Regional Universitaire Brest

Brest, Brittany Region, France

Hôpital Avicenne

Bobigny, France

Centre Hospitalier Regional Universitaire Brest

Brest, France

Hôpital François Mitterrand

Dijon, France

Hôpital Privé du Confluent

Nantes, France

Hopital Universitaire Pitie Salpetriere

Paris, France

Hôpital Haut-Lévêque

Pessac, France

Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

Rouen, France

Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

Heves, Budapest, Hungary

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László

Budapest, Pest County, Hungary

Semmelweis Egyetem

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Samson Assuta Ashdod University Hospital

Ashdod, Israel

Soroka Medical Center

Beersheba, Israel

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, Israel

Carmel Medical Center

Haifa, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

The Chaim Sheba Medical Center

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia, Italy

Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Ospedale Casa Sollievo della Sofferenza

Foggia, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

Meldola, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Milan, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Sanitaria Locale della Romagna

Ravenna, Italy

National Hospital Organization - Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Saitama Medical University - International Medical Center

Hidaka-Shi, Saitama, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Gifu Municipal Hospital

Gifu, Japan

Kagoshima University Hospital

Kagoshima, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, Japan

Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara

Guadalajara, Jalisco, Mexico

PanAmerican Clinical Research Mexico - Guadalajara

Guadalajara, Jalisco, Mexico

PanAmerican Clinical Research Mexico - Cuernavaca

Cuernavaca, Morelos, Mexico

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, Mexico

Hematológica Alta Especialidad

Huixquilucan, Mexico

Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México

Mexico City, Mexico

Hagaziekenhuis Van Den Haag - Leyweg

The Hague, South Holland, Netherlands

Elisabeth-TweeSteden Ziekenhuis - Elisabeth

Tilburg, Netherlands

Pratia MCM Kraków

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

Gdynia, Poland

Pratia Onkologia Katowice

Katowice, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Poland

Szpital Wojewódzki w Opolu

Opole, Poland

Centrum Medyczne Pratia Poznań

Skorzewo, Poland

Instytut Hematologii I Transfuzjologii

Warsaw, Poland

Hospital Español Auxilio Mutuo

San Juan, Puerto Rico

Hospital del Mar - Parc de Salut Mar

Barcelona, Spain

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Arnau de Vilanova

Valencia, Spain

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Özel Koru Hastanesi

Çukurambar, Ankara, Turkey (Türkiye)

VKV Amerikan Hastanesi

Şişli, Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Bornova, İzmir, Turkey (Türkiye)

Ondokuz Mayis Üniversitesi

Kurupelit, Samsun, Turkey (Türkiye)

Karadeniz Teknik Üniversitesi Tip Fakültesi

Ortahisar, Trabzon, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Turkey (Türkiye)

Mehmet Kemal Dedeman Hematoloji Hastanesi

Kayseri, Turkey (Türkiye)

The Royal Marsden NHS Foundation Trust

Sutton, England, United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom