New hope for hard-to-treat lymphoma: drug duo takes on cancer

NCT ID NCT04384484

Disease control Sponsor: ADC Therapeutics S.A. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug combination (loncastuximab tesirine plus rituximab) works better than standard chemotherapy for adults with diffuse large B-cell lymphoma that has returned or not improved after initial treatment. About 440 participants will be randomly assigned to receive either the new combo or standard care. The main goal is to see how long the cancer stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

440 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory diffuse large B-cell lymphoma Relapsed diffuse large B cell lymphoma

Contacts and locations

Locations

A Beneficência Portuguesa de São Paulo - Unidade Mirante

São Paulo, 01321-001, Brazil
Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, 8800, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, 8000, Belgium
Ankara Universitesi Tip Fakultesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, 06100, Turkey (Türkiye)
Azienda Ospedaliero - Universitaria Careggi

Florence, 50134, Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

Brescia, 25123, Italy
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México

Mexico City, 1120, Mexico
Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara

Guadalajara, Jalisco, 44600, Mexico
Carmel Medical Center

Haifa, 3436212, Israel
CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

Santiago, Santiago Metropolitan, 8330109, Chile
Centre Hospitalier Regional Universitaire Brest

Brest, Brittany Region, 29200, France
Centre Hospitalier Regional Universitaire Brest

Brest, 29200, France
Centre Hospitalier Universitaire Universite Catholique de Louvain

Namur, B-5530, Belgium
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

Rouen, 76038, France
Centro de Estudios Clínicos SAGA

Santiago, Santiago Metropolitan, 7500653, Chile
Centrum Medyczne Pratia Poznań

Skorzewo, 60-185, Poland
Chongqing University Cancer Hospital - Chongqing Cancer Hospital

Chongqing, 400030, China
Clinica Adventista Belgrano

Belgrano, Buenos Aires, C1430EGF, Argentina
Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares S.A.

Santa Fe, Buenos Aires, 3000, Argentina
Comprehensive Cancer Centers of Nevada - Henderson

Las Vegas, Nevada, 89169, United States
Cross Cancer Institute

Edmonton, T6G 1Z2, Canada
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László

Budapest, Pest County, 1097, Hungary
Ege Universitesi Tip Fakultesi Hastanesi

Bornova, İzmir, 35100, Turkey (Türkiye)
Elisabeth-TweeSteden Ziekenhuis - Elisabeth

Tilburg, 5022 GC, Netherlands
Fakultni Nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia
Fakultni nemocnice Ostrava

Ostrava, 708 52, Czechia
Fakultni nemocnice v Motole

Prague, 150 06, Czechia
Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy
Fukushima Medical University Hospital

Fukushima, 960-1295, Japan
Gifu Municipal Hospital

Gifu, 500-8323, Japan
Grupo Gamma - Hospital Privado Rosario

Rosario, Santa Fe Province, S2000GAP, Argentina
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China
Gunma Prefectural Cancer Center

Ōta, Gunma, 373-8550, Japan
Hagaziekenhuis Van Den Haag - Leyweg

The Hague, South Holland, 2545 AA, Netherlands
Hematológica Alta Especialidad

Huixquilucan, 52787, Mexico
Hemomed Instituto de Oncologia e Hematologia

São Paulo, 01236-030, Brazil
Henan Cancer Hospital - Zhengzhou University

Zhengzhou, Henan, 450008, China
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

Heves, Budapest, 3300, Hungary
Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan
Hollings Cancer Center

Charleston, South Carolina, 29425, United States
Hopital Universitaire Pitie Salpetriere

Paris, 75651, France
Hospital Arnau de Vilanova

Valencia, 25198, Spain
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Paraná, 81520-060, Brazil
Hospital Español Auxilio Mutuo

San Juan, 00919, Puerto Rico
Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil
Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital Mãe de Deus - Centro Integrado de Oncologia

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Hospital San Pedro de Alcantara

Cáceres, 10003, Spain
Hospital Santa Marcelina

São Paulo, 08270-120, Brazil
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain
Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen del Rocío

Seville, 41013, Spain
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil
Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain
Hospital do Câncer

Rio de Janeiro, 20230-130, Brazil
Huizhou Municipal Central Hospital

Huizhou, 516001, China
Hôpital Avicenne

Bobigny, 93000, France
Hôpital Fleurimont

Sherbrooke, J1H 5H3, Canada
Hôpital François Mitterrand

Dijon, 21000, France
Hôpital Haut-Lévêque

Pessac, 33604, France
Hôpital Privé du Confluent

Nantes, 44200, France
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, 08908, Spain
Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC

Tianjin, 300020, China
Instituto Médico Especializado Alexander Fleming

Buenos Aires, Distrito Federal, C1426ANZ, Argentina
Instituto Oncológico Fundación Arturo López Pérez

Santiago, Santiago Metropolitan, 8320000, Chile
Instytut Hematologii I Transfuzjologii

Warsaw, 02-776, Poland
Istituto Europeo di Oncologia

Milan, 20141, Italy
Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

Meldola, 47014, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Milan, 20089, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, 20132, Italy
Jilin Cancer Hospital

Changchun, Jilin, 130021, China
Kagoshima University Hospital

Kagoshima, 890-8520, Japan
Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, 97227, United States
Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan
Karadeniz Teknik Üniversitesi Tip Fakültesi

Ortahisar, Trabzon, 61080, Turkey (Türkiye)
Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan
Matsuyama Red Cross Hospital

Matsuyama, Ehime, 790-8524, Japan
Medical College of Wisconsin Cancer Center Clinical Trials Office

Milwaukee, Wisconsin, 53226, United States
Mehmet Kemal Dedeman Hematoloji Hastanesi

Kayseri, 38039, Turkey (Türkiye)
NHS Greater Glasgow and Clyde

Glasgow, G12 0XH, United Kingdom
Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan
National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization - Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan
National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, 190-0014, Japan
National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan
Niigata University Medical and Dental Hospital

Niigata, 951-8520, Japan
Norton Cancer Institute

Louisville, Kentucky, 40207, United States
Ondokuz Mayis Üniversitesi

Kurupelit, Samsun, 55270, Turkey (Türkiye)
Orszagos Onkologiai Intezet

Budapest, 1122, Hungary
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan
Ospedale Casa Sollievo della Sofferenza

Foggia, 71013, Italy
PanAmerican Clinical Research Mexico - Cuernavaca

Cuernavaca, Morelos, 62290, Mexico
PanAmerican Clinical Research Mexico - Guadalajara

Guadalajara, Jalisco, 44670, Mexico
Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China
Pratia MCM Kraków

Krakow, Lesser Poland Voivodeship, 30-510, Poland
Pratia Onkologia Katowice

Katowice, 40-519, Poland
Presidio Ospedaliero Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia, 33100, Italy
Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel
Redlands Community Hospital

Redlands, California, 92373, United States
Research Institute of the McGill University Health Centre

Montreal, H4A 3J1, Canada
Saitama Medical University - International Medical Center

Hidaka-Shi, Saitama, 350-1298, Japan
Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel
Sanitaria Locale della Romagna

Ravenna, 48121, Italy
Sapporo Hokuyu Hospital

Sapporo, Hokkaido, 003-0006, Japan
Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China
Semmelweis Egyetem

Budapest, 1088, Hungary
Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, 7030000, Israel
Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200025, China
Soroka Medical Center

Beersheba, 8410101, Israel
Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China
Szpital Wojewódzki w Opolu

Opole, 45-061, Poland
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

Gdynia, 81-519, Poland
Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel
The Chaim Sheba Medical Center

Tel Aviv, 52621, Israel
The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom
The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361001, China
The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China
The First Hospital of Jilin University

Changchun, Jilin, 130021, China
The Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States
The Royal Marsden NHS Foundation Trust

Sutton, England, SM2 5PT, United Kingdom
Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China
Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan
Tongji Hospital

Wuhan, 430030, China
Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, 441-8570, Japan
UnityPoint Health - Iowa Oncology Research Association (IORA)

Des Moines, Iowa, 50309, United States
University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland
VKV Amerikan Hastanesi

Şişli, Istanbul, 34365, Turkey (Türkiye)
Virginia Cancer Specialists

Gainesville, Virginia, 20155, United States
West China School of Medicine - West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, 93-510, Poland
Wuhan Union Hospital

Wuhan, 430023, China
Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China
Özel Koru Hastanesi

Çukurambar, Ankara, 6510, Turkey (Türkiye)

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