Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS 5)

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)

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

Study Overview

• Status: Recruiting
• Conditions: Refractory Diffuse Large B-Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: Rituximab; Drug: Loncastuximab Tesirine; Drug: Gemcitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ADC Therapeutics; Phone Number: 954-903-7994; Email: clinical.trials@adctherapeutics.com

Study Locations

• Argentina
  • Buenos Aires
    • Belgrano, Buenos Aires, Argentina, C1430EGF
      • Recruiting
      • Clinica Adventista Belgrano
      • Contact: Daiana Troncoso
    • Santa Fe, Buenos Aires, Argentina, 3000
      • Recruiting
      • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares S.A.
      • Contact: Melisa Chanda
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, C1426ANZ
      • Recruiting
      • Instituto Médico Especializado Alexander Fleming
      • Contact: Barbara Cibeira
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000GAP
      • Recruiting
      • Grupo Gamma - Hospital Privado Rosario
      • Contact: Jose Fedele
• Belgium
  • Brugge, Belgium, 8000
    • Recruiting
    • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
    • Contact: Sylvia Snauwaert
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Sarah Bailly
  • Namur, Belgium, B-5530
    • Recruiting
    • Centre Hospitalier Universitaire Universite Catholique de Louvain
    • Contact: Julien Depaus
  • Roeselare, Belgium, 8800
    • Recruiting
    • Algemeen Ziekenhuis Delta - Campus Rumbeke
    • Contact: Dries Deeren
• Brazil
  • Rio De Janeiro, Brazil, 20230-130
    • Recruiting
    • Hospital do Câncer
    • Contact: Letícia Souza
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Hospital Israelita Albert Einstein
    • Contact: Michelli Diniz
  • São Paulo, Brazil, 08270-120
    • Recruiting
    • Hospital Santa Marcelina
    • Contact: Luciane Clemente
  • São Paulo, Brazil, 01321-001
    • Recruiting
    • A Beneficência Portuguesa de São Paulo - Unidade Mirante
    • Contact: Danielle Leão Cordeiro de Farias
  • São Paulo, Brazil, 05403-010
    • Recruiting
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
    • Contact: Gabriela Facuri Ferretti
  • São Paulo, Brazil, 01236-030
    • Recruiting
    • Hemomed Instituto de Oncologia e Hematologia
    • Contact: Tamires Bezerra
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Recruiting
      • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
      • Contact: Thiago Miguel Silva
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Cinara Silveira
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Recruiting
      • Hospital Moinhos de Vento
      • Contact: Desiree Deconte
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
      • Recruiting
      • Hospital Mãe de Deus - Centro Integrado de Oncologia
      • Contact: Luis Felipe Castro
• Canada
  • Edmonton, Canada, T6G 1Z2
    • Recruiting
    • Cross Cancer Institute
    • Contact: Tara Rice
  • Montréal, Canada, H4A 3J1
    • Recruiting
    • Research Institute of the McGill University Health Centre
    • Contact: Kelly Davison
  • Sherbrooke, Canada, J1H 5H3
    • Recruiting
    • Hôpital Fleurimont
    • Contact: Dominique Toupin
• Chile
  • Región Metropolitana De Santiago
    • Santiago, Región Metropolitana De Santiago, Chile, 7500653
      • Recruiting
      • Centro de Estudios Clinicos SAGA
      • Contact: Carolina Bustos
    • Santiago, Región Metropolitana De Santiago, Chile, 8320000
      • Recruiting
      • Instituto Oncológico Fundación Arturo López Pérez
      • Contact: Joaquin Mateluna
    • Santiago, Región Metropolitana De Santiago, Chile, 8330109
      • Recruiting
      • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas
      • Contact: Ximena Fonck
• China
  • Chongqing, China, 400030
    • Recruiting
    • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
    • Contact: Yao Liu
  • Huizhou, China, 516001
    • Recruiting
    • Huizhou Municipal Central Hospital
    • Contact: Guowei Li
  • Nanchang, China, 330006
    • Recruiting
    • The First Affiliated Hospital of Nanchang University
    • Contact: Fei Li
  • Tianjin, China, 300020
    • Recruiting
    • Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC
    • Contact: Liu Wei
  • Wuhan, China, 430023
    • Recruiting
    • Wuhan Union Hospital
    • Contact: Liling Zhang
  • Wuhan, China, 430030
    • Recruiting
    • Tongji Hospital
    • Contact: Li Dengju
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Hongmei Jing
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Bing Xu
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: He Huang
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People'S Hospital
      • Contact: Wenyu Li
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang hospital of southern medical university
      • Contact: Yuhua Li
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital - Zhengzhou University
      • Contact: Yanyan Liu
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Sujun Gao
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Jilin Cancer Hospital
      • Contact: Ying Cheng
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • Recruiting
      • Second Affiliated Hospital of Dalian Medical University
      • Contact: Xiuhua Sun
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Cancer Center
      • Contact: Junning Cao
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China School of Medicine - West China Hospital of Sichuan University
      • Contact: Liqun Zou
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Zhengzi Qian
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jie Jin
• Czechia
  • Ostrava, Czechia, 708 52
    • Recruiting
    • Fakultni nemocnice Ostrava
    • Contact: Juraj Duras
  • Prague, Czechia, 100 34
    • Recruiting
    • Fakultní nemocnice Královské Vinohrady
    • Contact: Heidi Móciková
  • Prague, Czechia, 150 06
    • Recruiting
    • Fakultni nemocnice v Motole
    • Contact: Katerina Kopeckova
• France
  • Bobigny, France, 93000
    • Recruiting
    • Hôpital Avicenne
    • Contact: Thorsten Braun
  • Brest, France, 29200
    • Recruiting
    • Centre Hospitalier Regional Universitaire Brest
    • Contact: Adrian Tempescul
  • Nantes, France, 44200
    • Recruiting
    • Hopital Prive du Confluent
    • Contact: Katell Le Du
  • Paris, France, 75651
    • Recruiting
    • Hôpital Universitaire Pitié Salpêtrière
    • Contact: Sylvain Choquet
  • Pessac, France, 33604
    • Recruiting
    • Hôpital Haut-Lévêque
    • Contact: Kamal Bouabdallah
  • Rouen, France, 76038
    • Recruiting
    • Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
    • Contact: Fabrice Jardin
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Recruiting
      • Centre Hospitalier Regional Universitaire Brest
      • Contact: Adrian Tempescul
• Hungary
  • Budapest, Hungary, 1088
    • Recruiting
    • Semmelweis Egyetem
    • Contact: Zsolt Nagy
  • Budapest, Hungary, 1122
    • Recruiting
    • Országos Onkológiai Intézet
    • Contact: Andras Masszi
  • Budapest
    • Heves, Budapest, Hungary, 3300
      • Recruiting
      • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
      • Contact: Balazs Tajti
  • Pest
    • Budapest, Pest, Hungary, 1097
      • Recruiting
      • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László
      • Contact: Ottó Csacsovszki
• Israel
  • Ashdod, Israel, 7747629
    • Recruiting
    • Samson Assuta Ashdod University Hospital
    • Contact: Merav Leiba
  • Be'er Sheva, Israel, 8410101
    • Recruiting
    • Soroka Medical Center
    • Contact: Itai Levi
  • Be'er Ya'aqov, Israel, 7030000
    • Recruiting
    • Shamir Medical Center (Assaf Harofeh)
    • Contact: Maya Koren-Michowitz
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
    • Contact: Meir Preis
  • Petah tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center - Beilinson Hospital
    • Contact: Ronit Gurion
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Irit Avivi
  • Tel Aviv, Israel, 52621
    • Recruiting
    • The Chaim Sheba Medical Center
    • Contact: Abraham Avigdor
• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
    • Contact: Alessandra Tucci
  • Florence, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero - Universitaria Careggi
    • Contact: Benedetta Puccini
  • Foggia, Italy, 71013
    • Recruiting
    • Ospedale Casa Sollievo della Sofferenza
    • Contact: Potito Scalzulli
  • Meldola, Italy, 47014
    • Recruiting
    • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
    • Contact: Gerardo Musuraca
  • Milan, Italy, 20089
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
    • Contact: Carmello Carlo-Stella
  • Milan, Italy, 20132
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
    • Contact: Andrés José María Ferreri
  • Milano, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia
    • Contact: Enrico Derenzini
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Luca Arcaini
  • Ravenna, Italy, 48121
    • Recruiting
    • Sanitaria Locale della Romagna
    • Contact: Monica Tani
  • Friuli Venezia Giulia
    • Udine, Friuli Venezia Giulia, Italy, 33100
      • Recruiting
      • Presidio Ospedaliero Universitario Santa Maria della Misericordia
      • Contact: Jacopo Olivieri
• Japan
  • Fukushima, Japan, 960-1295
    • Recruiting
    • Fukushima Medical University Hospital
    • Contact: Takayuki Ikezoe
  • Gifu, Japan, 500-8323
    • Recruiting
    • Gifu Municipal Hospital
    • Contact: Senji Kasahara
  • Kagoshima, Japan, 890-8520
    • Recruiting
    • Kagoshima University Hospital
    • Contact: Kenji Ishitsuka
  • Niigata, Japan, 951-8520
    • Recruiting
    • Niigata University Medical and Dental Hospital
    • Contact: Jun Takizawa
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
    • Contact: Kazutaka Sunami
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
    • Contact: Jun Ishikawa
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • Recruiting
      • National Hospital Organization - Nagoya Medical Center
      • Contact: Hirokazu Nagai
    • Toyohashi, Aichi, Japan, 441-8570
      • Recruiting
      • Toyohashi Municipal Hospital
      • Contact: Shingo Murayama
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
      • Contact: Junichiro Yuda
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
      • Recruiting
      • Matsuyama Red Cross Hospital
      • Contact: Tomoaki Fujisaki
  • Gunma
    • Ota, Gunma, Japan, 373-8550
      • Recruiting
      • Gunma Prefectural Cancer Center
      • Contact: Kayoko Murayama
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • Recruiting
      • Hokkaido Cancer Center
      • Contact: Katsuya Fujimoto
    • Sapporo, Hokkaido, Japan, 003-0006
      • Recruiting
      • Sapporo Hokuyu Hospital
      • Contact: Shuichi Ota
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Recruiting
      • Kobe City Medical Center General Hospital
      • Contact: Tadakazu Kondo
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Cancer Center
      • Contact: Rika Sakai
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
      • Contact: Noriko Fukuhara
  • Nagasaki
    • Nagasaki-city, Nagasaki, Japan, 852-8501
      • Recruiting
      • Nagasaki University Hospital
      • Contact: Koji Ando
  • Saitama
    • Hidaka-Shi, Saitama, Japan, 350-1298
      • Recruiting
      • Saitama Medical University - International Medical Center
      • Contact: Kunihiro Tsukasaki
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8677
      • Recruiting
      • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Contact: Tatsu Shimoyama
    • Tachikawa, Tokyo, Japan, 190-0014
      • Recruiting
      • National Hospital Organization Disaster Medical Center
      • Contact: Naohiro Sekiguchi
• Mexico
  • Huixquilucan, Mexico, 52787
    • Recruiting
    • Hematologica Alta Especialidad
    • Contact: Carolina Cárcoba Tenorio
  • Mexico City, Mexico, 1120
    • Recruiting
    • Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México
    • Contact: Lizzette Alfaro
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Recruiting
      • Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara
      • Contact: Carolina Carcoba
    • Guadalajara, Jalisco, Mexico, 44670
      • Recruiting
      • Panamerican Clinical Research Mexico - Guadalajara
      • Contact: Felipe Arredondo
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • Recruiting
      • PanAmerican Clinical Research Mexico - Cuernavaca
      • Contact: Willy Patricio Flores; Email: eponce@panamclinicalresearch.com
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Recruiting
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez
      • Contact: María Eugenia García de León
• Netherlands
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • Elisabeth-TweeSteden Ziekenhuis - Elisabeth
    • Contact: Marc Durian
  • South Holland
    • Den Haag, South Holland, Netherlands, 2545 AA
      • Recruiting
      • Hagaziekenhuis Van Den Haag - Leyweg
• Poland
  • Gdynia, Poland, 81-519
    • Recruiting
    • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
    • Contact: Wanda Knopinska-Posluszny
  • Katowice, Poland, 40-519
    • Recruiting
    • Pratia Onkologia Katowice
    • Contact: Sebastian Grosicki
  • Opole, Poland, 45-061
    • Recruiting
    • Szpital Wojewodzki w Opolu
    • Contact: Dariusz Woszczyk
  • Skorzewo, Poland, 60-185
    • Recruiting
    • Centrum Medyczne Pratia Poznan
    • Contact: Michał Kwaitek
  • Warszawa, Poland, 02-776
    • Active, not recruiting
    • Instytut Hematologii i Transfuzjologii
  • Łódź, Poland, 93-510
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    • Contact: Piotr Smolewski
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-367
      • Active, not recruiting
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-510
      • Recruiting
      • PRATIA MCM Kraków
      • Contact: Wojciech Jurczak
• Puerto Rico
  • San Juan, Puerto Rico, 00919
    • Recruiting
    • Hospital Español Auxilio Mutuo
    • Contact: Ivanellys Arroyo Rivera
• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar - Parc de Salut Mar
    • Contact: Sergio Felipe Pinzon Marino
  • Barcelona, Spain, 08908
    • Recruiting
    • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
    • Contact: Eva Maria Gonzalez Barca
  • Cáceres, Spain, 10003
    • Recruiting
    • Hospital San Pedro de Alcantara
    • Contact: Juan Miguel Bergua Burgues
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón y Cajal
    • Contact: Francisco Javier Lopez Jimenez
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Victor Jimenez Yuste
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
    • Contact: Raul Mascunano
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marqués de Valdecilla
    • Contact: Sonia Gonzalez de Villambrosia
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocío
    • Contact: Fatima De La Cruz Vicente
  • Valencia, Spain, 25198
    • Recruiting
    • Hospital Arnau de Vilanova
    • Contact: Francisca López Chuliá
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Recruiting
    • Istituto Oncologico della Svizzera Italiana
    • Contact: Anastasios Stathis
• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi
    • Contact: Muhit Ozcan
  • Kayseri, Turkey, 38039
    • Recruiting
    • Mehmet Kemal Dedeman Hematoloji Hastanesi
    • Contact: Neslihan Sanli Mandaci
  • Ankara
    • Çukurambar, Ankara, Turkey, 6510
      • Recruiting
      • Özel Koru Hastanesi
      • Contact: Osman Ilhan
  • Istanbul
    • Şişli, Istanbul, Turkey, 34365
      • Recruiting
      • VKV Amerikan Hastanesi
      • Contact: Burhan Ferhanoğlu
  • Izmir
    • Bornova, Izmir, Turkey, 35100
      • Recruiting
      • Ege Universitesi Tip Fakultesi Hastanesi
      • Contact: Guray Saydam
  • Samsun
    • Kurupelit, Samsun, Turkey, 55270
      • Recruiting
      • Ondokuz Mayis Universitesi
      • Contact: Mehmet Turgut
  • Trabzon
    • Ortahisar, Trabzon, Turkey, 61080
      • Recruiting
      • Karadeniz Teknik Üniversitesi Tip Fakültesi
      • Contact: Mehmet Sonmez
• United Kingdom
  • Glasgow, United Kingdom, G12 0XH
    • Recruiting
    • NHS Greater Glasgow and Clyde
    • Contact: Pamela McKay
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
    • Contact: John Radford
  • England
    • Sutton, England, United Kingdom, SM2 5PT
      • Recruiting
      • The Royal Marsden NHS Foundation Trust
      • Contact: Ian Chau
• United States
  • California
    • Redlands, California, United States, 92373
      • Recruiting
      • Redlands Community Hospital
      • Contact: Patricia Ramos
    • Whittier, California, United States, 90603
      • Recruiting
      • The Oncology Institute of Hope and Innovation
      • Contact: Kirsten Bettino
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist MD Anderson Cancer Center
      • Contact: Maxim Norkin
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Recruiting
      • UnityPoint Health - Iowa Oncology Research Association (IORA)
      • Contact: Morgan Brown
      • Contact: Missy Straver
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
      • Contact: Joseph Maly
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Recruiting
      • Comprehensive Cancer Centers of Nevada - Henderson
      • Contact: Megan Wu
  • Oregon
    • Portland, Oregon, United States, 97227
      • Recruiting
      • Kaiser Permanente Interstate Medical Office Central
      • Contact: Abdul Hai Mansoor
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Hollings Cancer Center
      • Contact: Sarah Hogan
  • Virginia
    • Gainesville, Virginia, United States, 20155
      • Recruiting
      • Virginia Cancer Specialists
      • Contact: Mitul Gandhi, M.D.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin Cancer Center Clinical Trials Office
      • Contact: Sayed Mehdi Hamadani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female participant aged 18 years or older
• Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization classification (including participants with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
• Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen [For China only: Adequate first line anti-DLBCL therapy is defined as having received at least 4 cycles of multiagent systemic treatment regimen containing rituximab and anthracycline, unless the participants are intolerant to the regimen, or had disease progression during the treatment. If disease progression occurred during the treatment period, then the disease is considered refractory where the number of treatment cycles will not be specified. For participants who are ineligible for anthracycline, anthracycline is not required.]
• Not considered by the investigator to be a candidate for stem cell transplantation based on performance status, advanced age, and/or significant medical comorbidities such as organ dysfunction
• Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT
• Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available) Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred [For China only: This inclusion criterion is not applicable]
• ECOG performance status 0-2

• Adequate organ function as defined by screening laboratory values within the following parameters:

  1. Absolute neutrophil count ≥1000/μL (off growth factors for at least 72 hours)
  2. Platelet count ≥100000/μL without transfusion within the past 2 weeks
  3. ALT, AST, and GGT ≤2.5 × the upper limit of normal (ULN)
  4. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
  5. Calculated creatinine clearance ≥30 mL/min by the Cockcroft and Gault equation

Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.

• Negative beta-human chorionic gonadotropin (β-hCG) pregnancy test within 7 days prior to start of study drug (Cycle 1 Day 1) for women of childbearing potential
• Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 12 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 7 months after the participant receives his last dose of study treatment.

Exclusion Criteria:

• Previous treatment with loncastuximab tesirine
• Previous treatment with R-GemOx
• Known history of hypersensitivity to a CD19 antibody, loncastumiximab tesirine (including SG3249) or any of its excipients, or history of positive serum human ADA to a CD19 antibody
• Pathologic diagnosis of Burkitt lymphoma
• Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary
• Autologous transplant within 30 days prior to start of study drug (Cycle 1 Day 1)
• Allogeneic transplant within 60 days prior to start of study drug (Cycle 1 Day 1)
• Active graft-versus-host disease
• Post-transplantation lymphoproliferative disorders
• Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease

• Human immunodeficiency virus (HIV) seropositive with any of the following:

  1. CD4+ T-cell (CD4+) counts <350 cells/μL
  2. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
  3. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of screening
  4. HIV viral load ≥400 copies/mL
• Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
• Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis
• Lymphoma with active CNS involvement, including leptomeningeal disease
• Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
• Breastfeeding or pregnant
• Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the participant's ability to tolerate the study treatment
• Major surgery within 4 weeks prior to start of study drug (Cycle 1 Day 1); radiotherapy, chemotherapy or other antineoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1), except shorter if approved by the Sponsor
• Use of any other experimental medication within 14 days or 5 half-lives prior to start of study drug (Cycle 1 Day 1)
• Received live vaccine within 4 weeks of Cycle 1 Day 1
• Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non-hematologic toxicity (except alopecia) due to previous therapy prior to screening
• Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
• Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk
• Known history of hypersensitivity to oxaliplatin or other platinum-based drugs, or gemcitabine, or rituximab, or any of their excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R); Part 1 consists of a non-randomized safety run-in period evaluating the study drug for the first 20 participants. Participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m^2 Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m^2 Q3W for up to 6 additional cycles.	Drug: Rituximab; Intravenous Infusion; Drug: Loncastuximab Tesirine; Intravenous Infusion; Other Names: Zynlonta; ADCT-402
Experimental: Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R); Randomized participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m^2 every Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m^2 Q3W for up to 6 additional cycles.	Drug: Rituximab; Intravenous Infusion; Drug: Loncastuximab Tesirine; Intravenous Infusion; Other Names: Zynlonta; ADCT-402
Active Comparator: Part 2: Standard Immunochemotherapy (R-GemOx); Randomized participants will receive R-GemOx consisting of rituximab, gemcitabine and oxaliplatin as a standard immunochemotherapy treatment on Day 1 or Day 2 of each cycle for up to 8 cycles, where 1 Cycle is 2 weeks. R-GemOx will be administered via an intravenous infusion of rituximab 375 mg/m^2 + gemcitabine 1000 mg/m^2 + oxaliplatin 100 mg/m^2 every 2 weeks (Q2W) for up to 8 cycles.	Drug: Rituximab; Intravenous Infusion; Drug: Gemcitabine; Intravenous Infusion; Drug: Oxaliplatin; Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival (PFS)	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 4 years
Overall Response Rate (ORR)	Up to 4 years
Complete Response Rate (CRR)	Up to 4 years
Duration of Response (DOR)	Up to 4 years
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)	Up to 4 years
Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results	Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements	Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations	Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status	Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results	Day 1 up to a maximum of Week 25
Average Concentration of Loncastuximab Tesirine at the End of Infusion	Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine	Day 1 up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Core 30 (EORTC QLQ-C30)	Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Lymphoma Subscale of Functional Assessment of Cancer Therapy- Lymphoma (LymS of FACT-Lym)	Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by GP5 Item of the Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)	Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	Baseline to up to 4 years
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)	Day 1 up to a maximum of Week 39
Average Concentration of Loncastuximab Tesirine Before Infusion	Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)

Collaborators and Investigators

• Sponsor: ADC Therapeutics S.A.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lymphoma; Diffuse Large B-Cell Lymphoma; Loncastuximab Tesirine; Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Oxaliplatin; Rituximab; Loncastuximab tesirine; Gemcitabine
• Other Study ID Numbers: ADCT-402-311; 2020-000241-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No