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

April 24, 2026 updated by: ADC Therapeutics S.A.

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Belgrano, Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Santa Fe, Buenos Aires, Argentina, 3000
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares S.A.
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000GAP
        • Grupo Gamma - Hospital Privado Rosario
  • Belgium
      • Bruges, Belgium, 8000
        • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Namur, Belgium, B-5530
        • Centre Hospitalier Universitaire Universite Catholique de Louvain
      • Roeselare, Belgium, 8800
        • Algemeen Ziekenhuis Delta - Campus Rumbeke
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Hospital do Câncer
      • São Paulo, Brazil, 05652-900
        • Hospital Israelita Albert Einstein
      • São Paulo, Brazil, 05403-010
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
      • São Paulo, Brazil, 08270-120
        • Hospital Santa Marcelina
      • São Paulo, Brazil, 01236-030
        • Hemomed Instituto de Oncologia e Hematologia
      • São Paulo, Brazil, 01321-001
        • A Beneficência Portuguesa de São Paulo - Unidade Mirante
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Hospital Mãe de Deus - Centro Integrado de Oncologia
  • Canada
      • Edmonton, Canada, T6G 1Z2
        • Cross Cancer Institute
      • Montreal, Canada, H4A 3J1
        • Research Institute of the McGill University Health Centre
      • Sherbrooke, Canada, J1H 5H3
        • Hôpital Fleurimont
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500653
        • Centro de estudios clinicos SAGA
      • Santiago, Santiago Metropolitan, Chile, 8320000
        • Instituto Oncológico Fundación Arturo López Pérez
      • Santiago, Santiago Metropolitan, Chile, 8330109
        • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas
  • China
      • Chongqing, China, 400030
        • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
      • Huizhou, China, 516001
        • Huizhou Municipal Central Hospital
      • Nanchang, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Tianjin, China, 300020
        • Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC
      • Wuhan, China, 430023
        • Wuhan Union Hospital
      • Wuhan, China, 430030
        • Tongji Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
    • Fujian
      • Xiamen, Fujian, China, 361001
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital of Southern Medical University
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital - Zhengzhou University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130021
        • Jilin Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Second Affiliated Hospital of Dalian Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Shanghai Cancer center
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China School of Medicine - West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Czechia
      • Ostrava, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia, 100 34
        • Fakultní Nemocnice Královské Vinohrady
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • France
      • Bobigny, France, 93000
        • Hôpital Avicenne
      • Brest, France, 29200
        • Centre Hospitalier Regional Universitaire Brest
      • Dijon, France, 21000
        • Hôpital François Mitterrand
      • Nantes, France, 44200
        • Hôpital Privé du Confluent
      • Paris, France, 75651
        • Hôpital Universitaire Pitié Salpêtrière
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque
      • Rouen, France, 76038
        • Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Centre Hospitalier Regional Universitaire Brest
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
    • Budapest
      • Heves, Budapest, Hungary, 3300
        • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
    • Pest County
      • Budapest, Pest County, Hungary, 1097
        • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László
  • Israel
      • Ashdod, Israel, 7747629
        • Samson Assuta Ashdod University Hospital
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
      • Be’er Ya‘aqov, Israel, 7030000
        • Shamir Medical Center (Assaf Harofeh)
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center - Beilinson Hospital
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
      • Florence, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Foggia, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
      • Meldola, Italy, 47014
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
      • Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milan, Italy, 20132
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
      • Milan, Italy, 20089
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Ravenna, Italy, 48121
        • Sanitaria Locale della Romagna
    • Friuli Venezia Giulia
      • Udine, Friuli Venezia Giulia, Italy, 33100
        • Presidio Ospedaliero Universitario Santa Maria della Misericordia
  • Japan
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Gifu, Japan, 500-8323
        • Gifu Municipal Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical And Dental Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan, 541-8567
        • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • National Hospital Organization - Nagoya Medical Center
      • Toyohashi, Aichi-ken, Japan, 441-8570
        • Toyohashi Municipal Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0006
        • Sapporo Hokuyu Hospital
      • Sapporo, Hokkaido, Japan, 003-0804
        • Hokkaido Cancer Center
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
    • Saitama
      • Hidaka-Shi, Saitama, Japan, 350-1298
        • Saitama Medical University - International Medical Center
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Tachikawa, Tokyo, Japan, 190-0014
        • National Hospital Organization Disaster Medical Center
  • Mexico
      • Huixquilucan, Mexico, 52787
        • Hematologica Alta Especialidad
      • Mexico City, Mexico, 1120
        • Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara
      • Guadalajara, Jalisco, Mexico, 44670
        • PanAmerican Clinical Research Mexico - Guadalajara
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • PanAmerican Clinical Research Mexico - Cuernavaca
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Netherlands
      • Tilburg, Netherlands, 5022 GC
        • Elisabeth-TweeSteden Ziekenhuis - Elisabeth
    • South Holland
      • The Hague, South Holland, Netherlands, 2545 AA
        • Hagaziekenhuis Van Den Haag - Leyweg
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
      • Katowice, Poland, 40-519
        • Pratia Onkologia Katowice
      • Lodz, Poland, 93-510
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
      • Opole, Poland, 45-061
        • Szpital Wojewodzki w Opolu
      • Skorzewo, Poland, 60-185
        • Centrum Medyczne Pratia Poznań
      • Warsaw, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-510
        • PRATIA MCM Kraków
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Puerto Rico
      • San Juan, Puerto Rico, 00919
        • Hospital Español Auxilio Mutuo
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar - Parc de Salut Mar
      • Barcelona, Spain, 08908
        • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 25198
        • Hospital Arnau de Vilanova
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Istituto Oncologico della Svizzera Italiana
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi
      • Kayseri, Turkey (Türkiye), 38039
        • Mehmet Kemal Dedeman Hematoloji Hastanesi
    • Ankara
      • Çukurambar, Ankara, Turkey (Türkiye), 6510
        • Özel Koru Hastanesi
    • Istanbul
      • Şişli, Istanbul, Turkey (Türkiye), 34365
        • VKV Amerikan Hastanesi
    • Samsun
      • Kurupelit, Samsun, Turkey (Türkiye), 55270
        • Ondokuz Mayis Üniversitesi
    • Trabzon
      • Ortahisar, Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Teknik Universitesi Tip Fakultesi
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Ege Universitesi Tip Fakultesi Hastanesi
  • United Kingdom
      • Glasgow, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University Of California San Diego Moores Cancer Center
      • Redlands, California, United States, 92373
        • Redlands Community Hospital
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope and Innovation
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • UnityPoint Health - Iowa Oncology Research Association (IORA)
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Henderson
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Interstate Medical Office Central
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center Clinical Trials Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 4 years
Up to 4 years
Overall Response Rate (ORR)
Time Frame: Up to 4 years
Up to 4 years
Complete Response Rate (CRR)
Time Frame: Up to 4 years
Up to 4 years
Duration of Response (DOR)
Time Frame: Up to 4 years
Up to 4 years
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
Time Frame: Up to 4 years
Up to 4 years
Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
Time Frame: Day 1 up to a maximum of Week 25
Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
Time Frame: Day 1 up to a maximum of Week 25
Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
Time Frame: Day 1 up to a maximum of Week 25
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
Time Frame: Day 1 up to a maximum of Week 25
Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
Time Frame: Day 1 up to a maximum of Week 25
Day 1 up to a maximum of Week 25
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Time Frame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time Frame: Day 1 up to a maximum of Week 25
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)
Time Frame: Baseline up to a maximum of Week 25
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)
Time Frame: Baseline up to a maximum of Week 25
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)
Time Frame: Baseline up to a maximum of Week 25
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)
Time Frame: Baseline to up to 4 years
Baseline to up to 4 years
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Day 1 up to a maximum of Week 39
Day 1 up to a maximum of Week 39
Average Concentration of Loncastuximab Tesirine Before Infusion
Time Frame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADC Therapeutics S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Actual)

March 31, 2026

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)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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