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

Primary Purpose

Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Loncastuximab Tesirine
Rituximab
Gemcitabine
Oxaliplatin
Sponsored by
ADC Therapeutics S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Diffuse Large B-Cell Lymphoma focused on measuring Loncastuximab Tesirine, Refractory Diffuse Large B-Cell Lymphoma, Relapsed Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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
  • Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy
  • 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
  • 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 6 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 or 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

Sites / Locations

  • University of California San Diego Moores Cancer CenterRecruiting
  • Redlands Community HospitalRecruiting
  • The Oncology Institute of Hope and InnovationRecruiting
  • Baptist MD Anderson Cancer CenterRecruiting
  • UnityPoint Health - Iowa Oncology Research Association (IORA)Recruiting
  • Norton Cancer InstituteRecruiting
  • Comprehensive Cancer Centers of Nevada - HendersonRecruiting
  • Kaiser Permanente Interstate Medical Office CentralRecruiting
  • Hollings Cancer CenterRecruiting
  • Texas Oncology Corporate Office
  • Huntsman Cancer Institute and Hospital
  • Virginia Cancer SpecialistsRecruiting
  • Medical College of Wisconsin Cancer Center Clinical Trials OfficeRecruiting
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-JanRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Centre Hospitalier Universitaire Universite Catholique de LouvainRecruiting
  • Algemeen Ziekenhuis Delta - Campus RumbekeRecruiting
  • Cross Cancer InstituteRecruiting
  • Research Institute of the McGill University Health CentreRecruiting
  • Hôpital FleurimontRecruiting
  • Peking University Third HospitalRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Henan Cancer Hospital - Zhengzhou UniversityRecruiting
  • Jilin Cancer HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Shanghai Cancer CenterRecruiting
  • West China School of Medicine - West China Hospital of Sichuan UniversityRecruiting
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • The First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Chongqing University Cancer Hospital - Chongqing Cancer HospitalRecruiting
  • Huizhou Municipal Central HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Institute of Hematology and Blood Diseases Hospital of CAMS - PUMCRecruiting
  • Wuhan Union HospitalRecruiting
  • Tongji HospitalRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Fakultni Nemocnice Kralovske VinohradyRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • Hôpital AvicenneRecruiting
  • Centre Hospitalier Regional Universitaire BrestRecruiting
  • CHU Dijon Bourgogne - Hôpital François MitterrandRecruiting
  • Hôpital Privé du ConfluentRecruiting
  • Hopital Universitaire Pitie SalpetriereRecruiting
  • Hôpital Haut-LévêqueRecruiting
  • Centre de Lutte Contre le Cancer - Centre Henri-BecquerelRecruiting
  • Semmelweis EgyetemRecruiting
  • Orszagos Onkologiai IntezetRecruiting
  • Samson Assuta Ashdod University HospitalRecruiting
  • Soroka Medical CenterRecruiting
  • Shamir Medical Center (Assaf Harofeh)Recruiting
  • Carmel Medical CenterRecruiting
  • Rabin Medical Center - Beilinson HospitalRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Presidio Ospedaliero Universitario Santa Maria della MisericordiaRecruiting
  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliero - Universitaria CareggiRecruiting
  • Ospedale Casa Sollievo della SofferenzaRecruiting
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRSTRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico HumanitasRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San RaffaeleRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Sanitaria Locale della RomagnaRecruiting
  • Azienda Ospedaliera Universitaria Integrata VeronaRecruiting
  • Boca Raton Clinical Research (BRCR) Global Mexico - GuadalajaraRecruiting
  • PanAmerican Clinical Research Mexico - GuadalajaraRecruiting
  • PanAmerican Clinical Research Mexico - CuernavacaRecruiting
  • Hematológica Alta EspecialidadRecruiting
  • Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de MéxicoRecruiting
  • Hagaziekenhuis Van Den Haag - LeywegRecruiting
  • Elisabeth-TweeSteden Ziekenhuis - ElisabethRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
  • Pratia MCM KrakówRecruiting
  • Szpitale Pomorskie Spółka Z Ograniczoną OdpowiedzialnościąRecruiting
  • Pratia Onkologia KatowiceRecruiting
  • Szpital Wojewódzki w OpoluRecruiting
  • Centrum Medyczne Pratia PoznańRecruiting
  • Instytut Hematologii I TransfuzjologiiRecruiting
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziRecruiting
  • Hospital del Mar - Parc de Salut MarRecruiting
  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)Recruiting
  • Juan Miguel Bergua BurguesRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario Fundación Jiménez DíazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Arnau de VilanovaRecruiting
  • Istituto Oncologico della Svizzera ItalianaRecruiting
  • The Royal Marsden NHS Foundation TrustRecruiting
  • NHS Greater Glasgow and ClydeRecruiting
  • The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)

Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)

Part 2: Standard Immunochemotherapy (R-GemOx)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)
Overall Response Rate (ORR)
Complete Response Rate (CRR)
Duration of Response (DOR)
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Average Concentration of Loncastuximab Tesirine Before Infusion
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
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)
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)
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)
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Full Information

First Posted
May 8, 2020
Last Updated
September 18, 2023
Sponsor
ADC Therapeutics S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04384484
Brief Title
Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym
LOTIS 5
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADC Therapeutics S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
Keywords
Loncastuximab Tesirine, Refractory Diffuse Large B-Cell Lymphoma, Relapsed Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Standard Immunochemotherapy (R-GemOx)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Loncastuximab Tesirine
Other Intervention Name(s)
Zynlonta, ADCT-402
Intervention Description
Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Intravenous Infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to 4 years
Title
Overall Response Rate (ORR)
Time Frame
Up to 4 years
Title
Complete Response Rate (CRR)
Time Frame
Up to 4 years
Title
Duration of Response (DOR)
Time Frame
Up to 4 years
Title
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame
Day 1 up to a maximum of Week 39
Title
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
Time Frame
Up to 4 years
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Time Frame
Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Title
Average Concentration of Loncastuximab Tesirine Before Infusion
Time Frame
Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Title
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time Frame
Day 1 up to a maximum of Week 25
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ADC Therapeutics
Phone
954-903-7994
Email
clinical.trials@adctherapeutics.com
Facility Information:
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Chung
Facility Name
Redlands Community Hospital
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Ramos
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bettino
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Norkin
Facility Name
UnityPoint Health - Iowa Oncology Research Association (IORA)
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Brown
First Name & Middle Initial & Last Name & Degree
Missy Straver
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Maly
Facility Name
Comprehensive Cancer Centers of Nevada - Henderson
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Wu
Facility Name
Kaiser Permanente Interstate Medical Office Central
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Hai Mansoor
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hogan
Facility Name
Texas Oncology Corporate Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Completed
Facility Name
Huntsman Cancer Institute and Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
841112
Country
United States
Individual Site Status
Completed
Facility Name
Virginia Cancer Specialists
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitul Gandhi, M.D.
Facility Name
Medical College of Wisconsin Cancer Center Clinical Trials Office
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sayed Mehdi Hamadani
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Snauwaert
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Bailly
Facility Name
Centre Hospitalier Universitaire Universite Catholique de Louvain
City
Namur
ZIP/Postal Code
B-5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Depaus
Facility Name
Algemeen Ziekenhuis Delta - Campus Rumbeke
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Deeren
Facility Name
Cross Cancer Institute
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Rice
Facility Name
Research Institute of the McGill University Health Centre
City
Montréal
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Davison
Facility Name
Hôpital Fleurimont
City
Sherbrooke
ZIP/Postal Code
J1H 5H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Toupin
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei Jing
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Xu
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhua Li
Facility Name
Henan Cancer Hospital - Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujun Gao
Facility Name
Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhua Sun
Facility Name
Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junning Cao
Facility Name
West China School of Medicine - West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Zou
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengzi Qian
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Facility Name
Chongqing University Cancer Hospital - Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Liu
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guowei Li
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Wei
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liling Zhang
Facility Name
Tongji Hospital
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Dengju
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juraj Duras
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Móciková
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katerina Kopeckova
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Braun
Facility Name
Centre Hospitalier Regional Universitaire Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Tempescul
Facility Name
CHU Dijon Bourgogne - Hôpital François Mitterrand
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René-Olivier Casasnovas
Facility Name
Hôpital Privé du Confluent
City
Nantes
ZIP/Postal Code
44200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katell Le Du
Facility Name
Hopital Universitaire Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Choquet
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal Bouabdallah
Facility Name
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Jardin
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Nagy
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andras Masszi
Facility Name
Samson Assuta Ashdod University Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merav Leiba
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itai Levi
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Be'er Ya'aqov
ZIP/Postal Code
7030000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Koren-Michowitz
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meir Preis
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronit Gurion
Facility Name
The Chaim Sheba Medical Center
City
Tel Aviv
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham Avigdor
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Avivi
Facility Name
Presidio Ospedaliero Universitario Santa Maria della Misericordia
City
Udine
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacopo Olivieri
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Tucci
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetta Puccini
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
Foggia
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Potito Scalzulli
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Musuraca
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Derenzini
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmello Carlo-Stella
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés José María Ferreri
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Arcaini
Facility Name
Sanitaria Locale della Romagna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Tani
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Benedetti
Facility Name
Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Carcoba
Facility Name
PanAmerican Clinical Research Mexico - Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Arredondo
Facility Name
PanAmerican Clinical Research Mexico - Cuernavaca
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willy Patricio Flores
Email
eponce@panamclinicalresearch.com
Facility Name
Hematológica Alta Especialidad
City
Huixquilucan
ZIP/Postal Code
52787
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Cárcoba Tenorio
Facility Name
Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México
City
Mexico City
ZIP/Postal Code
1120
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizzette Alfaro
Facility Name
Hagaziekenhuis Van Den Haag - Leyweg
City
Den Haag
State/Province
South Holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elisabeth-TweeSteden Ziekenhuis - Elisabeth
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Durian
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Wrobel
Facility Name
Pratia MCM Kraków
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Jurczak
Facility Name
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanda Knopinska-Posluszny
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Grosicki
Facility Name
Szpital Wojewódzki w Opolu
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dariusz Woszczyk
Facility Name
Centrum Medyczne Pratia Poznań
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał Kwaitek
Facility Name
Instytut Hematologii I Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Lech-Maranda
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Smolewski
Facility Name
Hospital del Mar - Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Felipe Pinzon Marino
Facility Name
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Maria Gonzalez Barca
Facility Name
Juan Miguel Bergua Burgues
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Miguel Bergua Burgues
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Lopez Jimenez
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Mascunano
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tycho Baumann
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Jimenez Yuste
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Gonzalez de Villambrosia
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima De La Cruz Vicente
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisca López Chuliá
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasios Stathis
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Chau
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela McKay
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Radford

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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