AzTrials
AzTrials

Relapsed Diffuse Large B-Cell LymphomaPhase 3LOTIS 5NCT04384484

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

A Phase 3 study testing Loncastuximab Tesirine, Rituximab and Gemcitabine in people with Relapsed Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by ADC Therapeutics S.A. at 144 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Loncastuximab Tesirine, Rituximab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
144 sitesin 21 countries
Study dates
16 Sep 2020to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]
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  • ECOG performance status 0-2
  • Adequate organ function as defined by screening laboratory values within the following parameters:
  • Absolute neutrophil count ≥1000/μL (off growth factors for at least 72 hours)
  • Platelet count ≥100000/μL without transfusion within the past 2 weeks
  • ALT, AST, and GGT ≤2.5 × the upper limit of normal (ULN)
  • Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
  • 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.

Who cannot join

  • 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)
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  • 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:
  • CD4+ T-cell (CD4+) counts <350 cells/μL
  • Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
  • Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of screening
  • 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

Trial locations and contacts

144 sites in 21 countries.

144 sites in 21 countries

Japan20 sites

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Gifu Municipal Hospital

    Gifu, 500-8323

  • Saitama Medical University - International Medical Center

    Hidaka-Shi, Saitama, 350-1298

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790-8524

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • National Hospital Organization - Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • Sapporo Hokuyu Hospital

    Sapporo, Hokkaido, 003-0006

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • National Hospital Organization Disaster Medical Center

    Tachikawa, Tokyo, 190-0014

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

China19 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

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

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital - Chongqing Cancer Hospital

    Chongqing, 400030

  • Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200025

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC

    Tianjin, 300020

  • Wuhan Union Hospital

    Wuhan, 430023

  • Tongji Hospital

    Wuhan, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001

  • Henan Cancer Hospital - Zhengzhou University

    Zhengzhou, Henan, 450008

Other trials in China

United States11 sites

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • UnityPoint Health - Iowa Oncology Research Association (IORA)

    Des Moines, Iowa, 50309

  • Virginia Cancer Specialists

    Gainesville, Virginia, 20155

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada - Henderson

    Las Vegas, Nevada, 89169

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Medical College of Wisconsin Cancer Center Clinical Trials Office

    Milwaukee, Wisconsin, 53226

  • Kaiser Permanente Interstate Medical Office Central

    Portland, Oregon, 97227

  • Redlands Community Hospital

    Redlands, California, 92373

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

Other trials in United States

Brazil10 sites

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, Paraná, 81520-060

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mãe de Deus - Centro Integrado de Oncologia

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital do Câncer

    Rio de Janeiro, 20230-130

  • Hemomed Instituto de Oncologia e Hematologia

    São Paulo, 01236-030

  • A Beneficência Portuguesa de São Paulo - Unidade Mirante

    São Paulo, 01321-001

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

    São Paulo, 05403-010

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900

  • Hospital Santa Marcelina

    São Paulo, 08270-120

Other trials in Brazil

Italy10 sites

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

    Brescia, 25123

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • Ospedale Casa Sollievo della Sofferenza

    Foggia, 71013

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

    Meldola, 47014

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

    Milan, 20089

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

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Sanitaria Locale della Romagna

    Ravenna, 48121

  • Presidio Ospedaliero Universitario Santa Maria della Misericordia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Spain10 sites

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003

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

    Barcelona, 08908

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Arnau de Vilanova

    Valencia, 25198

Other trials in Spain

France8 sites

  • Hôpital Avicenne

    Bobigny, 93000

  • Centre Hospitalier Regional Universitaire Brest

    Brest, Brittany Region, 29200

  • Centre Hospitalier Regional Universitaire Brest

    Brest, 29200

  • Hôpital François Mitterrand

    Dijon, 21000

  • Hôpital Privé du Confluent

    Nantes, 44200

  • Hopital Universitaire Pitie Salpetriere

    Paris, 75651

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

    Rouen, 76038

Other trials in France

Poland8 sites

  • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

    Gdynia, 81-519

  • Pratia Onkologia Katowice

    Katowice, 40-519

  • Pratia MCM Kraków

    Krakow, Lesser Poland Voivodeship, 30-510

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

    Lodz, 93-510

  • Szpital Wojewódzki w Opolu

    Opole, 45-061

  • Centrum Medyczne Pratia Poznań

    Skorzewo, 60-185

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

Israel7 sites

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7030000

  • Soroka Medical Center

    Beersheba, 8410101

  • Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Tel Aviv, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)7 sites

  • Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi

    Ankara, 06100

  • Ege Universitesi Tip Fakultesi Hastanesi

    Bornova, İzmir, 35100

  • Özel Koru Hastanesi

    Çukurambar, Ankara, 6510

  • Mehmet Kemal Dedeman Hematoloji Hastanesi

    Kayseri, 38039

  • Ondokuz Mayis Üniversitesi

    Kurupelit, Samsun, 55270

  • Karadeniz Teknik Üniversitesi Tip Fakültesi

    Ortahisar, Trabzon, 61080

  • VKV Amerikan Hastanesi

    Şişli, Istanbul, 34365

Other trials in Turkey (Türkiye)

Mexico6 sites

  • PanAmerican Clinical Research Mexico - Cuernavaca

    Cuernavaca, Morelos, 62290

  • Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara

    Guadalajara, Jalisco, 44600

  • PanAmerican Clinical Research Mexico - Guadalajara

    Guadalajara, Jalisco, 44670

  • Hematológica Alta Especialidad

    Huixquilucan, 52787

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

    Mexico City, 1120

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Argentina4 sites

  • Clinica Adventista Belgrano

    Belgrano, Buenos Aires, C1430EGF

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, Distrito Federal, C1426ANZ

  • Grupo Gamma - Hospital Privado Rosario

    Rosario, Santa Fe Province, S2000GAP

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

    Santa Fe, Buenos Aires, 3000

Other trials in Argentina

Belgium4 sites

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

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Centre Hospitalier Universitaire Universite Catholique de Louvain

    Namur, B-5530

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare, 8800

Other trials in Belgium

Hungary4 sites

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

    Budapest, Pest County, 1097

  • Semmelweis Egyetem

    Budapest, 1088

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

    Heves, Budapest, 3300

Other trials in Hungary

Canada3 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • Research Institute of the McGill University Health Centre

    Montreal, H4A 3J1

  • Hôpital Fleurimont

    Sherbrooke, J1H 5H3

Other trials in Canada

Chile3 sites

  • Centro de Estudios Clínicos SAGA

    Santiago, Santiago Metropolitan, 7500653

  • Instituto Oncológico Fundación Arturo López Pérez

    Santiago, Santiago Metropolitan, 8320000

  • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

    Santiago, Santiago Metropolitan, 8330109

Other trials in Chile

Czechia3 sites

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

United Kingdom3 sites

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Netherlands2 sites

  • Hagaziekenhuis Van Den Haag - Leyweg

    The Hague, South Holland, 2545 AA

  • Elisabeth-TweeSteden Ziekenhuis - Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

Puerto Rico1 site

  • Hospital Español Auxilio Mutuo

    San Juan, 00919

Other trials in Puerto Rico

Switzerland1 site

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

Other trials in Switzerland

About this study

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)

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

Being tested
Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Keywords
Loncastuximab Tesirine, Refractory Diffuse Large B-Cell Lymphoma, Relapsed Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loncastuximab TesirineDrug

    Also called Zynlonta, ADCT-402

    Intravenous Infusion

  • RituximabDrug

    Intravenous Infusion

  • GemcitabineDrug

    Intravenous Infusion

  • OxaliplatinDrug

    Intravenous Infusion

Study groups in NCT04384484
Study groupRoleWhat they receive
Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)ExperimentalPart 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.
Receives: Drug: Loncastuximab Tesirine; Drug: Rituximab
Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)ExperimentalRandomized 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.
Receives: Drug: Loncastuximab Tesirine; Drug: Rituximab
Part 2: Standard Immunochemotherapy (R-GemOx)Active comparatorRandomized 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.
Receives: Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Measured: Up to 4 years

Secondary outcomes (18)

  1. Overall Survival (OS)

    Measured: Up to 4 years

  2. Overall Response Rate (ORR)

    Measured: Up to 4 years

  3. Complete Response Rate (CRR)

    Measured: Up to 4 years

  4. Duration of Response (DOR)

    Measured: Up to 4 years

  5. Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)

    Measured: Day 1 up to a maximum of Week 39

  6. Number of Participants Who Experience At Least One Serious Adverse Event (SAE)

    Measured: Up to 4 years

  7. Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results

    Measured: Day 1 up to a maximum of Week 25

  8. Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements

    Measured: Day 1 up to a maximum of Week 25

  9. Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations

    Measured: Day 1 up to a maximum of Week 25

  10. Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

    Measured: Day 1 up to a maximum of Week 25

  11. Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results

    Measured: Day 1 up to a maximum of Week 25

  12. Average Concentration of Loncastuximab Tesirine at the End of Infusion

    Measured: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)

  13. Average Concentration of Loncastuximab Tesirine Before Infusion

    Measured: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)

  14. Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine

    Measured: Day 1 up to a maximum of Week 25

  15. 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)

    Measured: Baseline up to a maximum of Week 25

  16. 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)

    Measured: Baseline up to a maximum of Week 25

  17. 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)

    Measured: Baseline up to a maximum of Week 25

  18. Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    Measured: Baseline to up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start16 Sep 2020
  3. Primary completion31 Mar 2026
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384484
Sponsor's protocol ID
ADCT-402-311
Other IDs
2020-000241-14
Acronym
LOTIS 5
Status last verified
Apr 2026
First submitted
8 May 2020
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Loncastuximab Tesirine, Rituximab and Gemcitabine in people with Relapsed Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by ADC Therapeutics S.A. at 144 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in Japan, China, United States, Brazil, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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