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Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3)

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Lenalidomide
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Double-hit lymphoma, Triple-hit lymphoma, Follicular grade 3B, T-cell/histiocyte rich LBCL, DuoBody®, Anti-CD3, Anti-CD20, Subcutaneous, Bispecific antibody, EPCORE

Eligibility Criteria

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

Inclusion Criteria: Must have newly diagnosed CD20+ large cell lymphoma. Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: Being age ≥80 years; AND/OR Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy. Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10. Have Ann Arbor Stage II-IV disease. Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment). Have measurable disease as per Lugano criteria. Have acceptable organ function based on baseline bloodwork. Must have fresh (preferred) or archival biopsy material at screening. Exclusion Criteria: Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection. Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy), Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: Major surgery within 4 weeks prior to the first dose of epcoritamab; Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; Live, attenuated vaccines within 30 days prior to initiation of epcoritamab; Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed); Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab. Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture. Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form. Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol. Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS). Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis. Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment. Has suspected active or inadequately treated latent tuberculosis. Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards. Note: Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

  • UW Cancer Center at ProHealth Care
  • Kepler UniversitätsklinikumRecruiting
  • LKH - Universitätsklinikum der PMU SalzburgRecruiting
  • Klinikum Wels-Grieskirchen GmbHRecruiting
  • ZNARecruiting
  • GZA ZiekenhuizenRecruiting
  • Institut Jules BordetRecruiting
  • Universitair Ziekenhuis BrusselRecruiting
  • UZ LeuvenRecruiting
  • AZ DeltaRecruiting
  • VitazRecruiting
  • AZ Turnhout - Campus Sint-ElisabethRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • CHU de Bordeaux - Hôpital Haut-LévêqueRecruiting
  • CHU Amiens - Hopital SudRecruiting
  • Hopital Claude Huriez - CHRU LilleRecruiting
  • Hopital de la Conception - APHMRecruiting
  • CHU Angers - Hôpital Hôtel DieuRecruiting
  • CHU de Nantes - Hotel DieuRecruiting
  • CHU Tours - Hôpital BretonneauRecruiting
  • Centre Antoine LacassagneRecruiting
  • Hôpital Henri MondorRecruiting
  • Hôpital Saint-AntoineRecruiting
  • Hôpital Saint-LouisRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Asan Medical CenterRecruiting
  • National Cancer CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Pratia MCMRecruiting
  • Centrum Medyczne PratiaRecruiting
  • MICS Centrum MedyczneRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
  • Hospital San Pedro de AlcantaraRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario Nuestra Señora de ValmeRecruiting
  • Hospital Universitario Puerta del MarRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Bristol Haematology and Oncology Centre
  • Royal Marsden Hospital - Fulham
  • Churchill HospitalRecruiting
  • Royal Marsden Hospital
  • Derriford HospitalRecruiting
  • Southampton General HospitalRecruiting
  • Royal Cornwall HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epcoritamab monotherapy

Epcoritamab in combination with lenalidomide

Arm Description

Outcomes

Primary Outcome Measures

Complete Response (CR) rate
Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria

Secondary Outcome Measures

Duration of response (DOR)
Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first
Duration of complete response (DOCR)
Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first
Time to response (TTR)
Defined as the time from first dose to first documentation of objective tumor response (CR or PR)
Overall Response Rate (ORR)
Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria
Progression-free survival (PFS)
Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first
Time to next anti-lymphoma therapy (TTNT)
Defined as the time from first dose to administration of subsequent anti-lymphoma therapy
Rate of minimal residual disease (MRD) negativity
Percentage of participants with at least 1 post-screening MRD negative result
Overall survival (OS)
Defined at the timeframe from first dose to death
Incidence and severity of adverse events (AEs)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Incidence of clinically significant shifts in laboratory parameters
Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, cardiac enzymes, immunoglobulins, and urinalyses
Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma
To evaluate immunogenicity
Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life
Assess pharmacokinetics (PK) of epcoritamab
Total body clearance of drug from the plasma (CL)
Assess pharmacokinetics (PK) of epcoritamab
Volume of Distribution
Assess pharmacokinetics (PK) of epcoritamab
Area Under the Concentration-Time Curve (AUC) from Time 0 to last quantifiable sample
Assess pharmacokinetics (PK) of epcoritamab
Area Under the Concentration-Time Curve (AUC) from Time 0 to infinity
Assess pharmacokinetics (PK) of epcoritamab
Maximum observed concentration (Cmax)
Assess pharmacokinetics (PK) of epcoritamab
Time to reach Cmax (Tmax)
Assess pharmacokinetics (PK) of epcoritamab
Terminal Elimination Half-Life (t 1/2)

Full Information

First Posted
November 29, 2022
Last Updated
October 2, 2023
Sponsor
Genmab
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05660967
Brief Title
Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma
Acronym
EPCORE DLBCL-3
Official Title
Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
AbbVie

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 the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.
Detailed Description
This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible. The trial is designed in two stages: Stage 1 which includes a safety run-in phase in each arm Stage 2, an expansion of the selected treatment from Stage 1

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
Double-hit lymphoma, Triple-hit lymphoma, Follicular grade 3B, T-cell/histiocyte rich LBCL, DuoBody®, Anti-CD3, Anti-CD20, Subcutaneous, Bispecific antibody, EPCORE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epcoritamab monotherapy
Arm Type
Experimental
Arm Title
Epcoritamab in combination with lenalidomide
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3×CD20, EPKINLY™
Intervention Description
Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid®
Intervention Description
Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.
Primary Outcome Measure Information:
Title
Complete Response (CR) rate
Description
Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Duration of complete response (DOCR)
Description
Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Time to response (TTR)
Description
Defined as the time from first dose to first documentation of objective tumor response (CR or PR)
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year
Title
Overall Response Rate (ORR)
Description
Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Progression-free survival (PFS)
Description
Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Time to next anti-lymphoma therapy (TTNT)
Description
Defined as the time from first dose to administration of subsequent anti-lymphoma therapy
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Rate of minimal residual disease (MRD) negativity
Description
Percentage of participants with at least 1 post-screening MRD negative result
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years
Title
Overall survival (OS)
Description
Defined at the timeframe from first dose to death
Time Frame
From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years
Title
Incidence and severity of adverse events (AEs)
Description
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Time Frame
From screening until end of the safety follow-up period (60 days after last dose)
Title
Incidence of clinically significant shifts in laboratory parameters
Description
Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, cardiac enzymes, immunoglobulins, and urinalyses
Time Frame
From screening until end of the safety follow-up period (60 days after last dose)
Title
Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma
Description
To evaluate immunogenicity
Time Frame
From first dose until treatment discontinuation (assessed up to 12 months)
Title
Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms
Description
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life
Time Frame
From cycle 1, day 1 until 90 days after last dose (each cycle is 28 days)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Total body clearance of drug from the plasma (CL)
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Volume of Distribution
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Area Under the Concentration-Time Curve (AUC) from Time 0 to last quantifiable sample
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Area Under the Concentration-Time Curve (AUC) from Time 0 to infinity
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Maximum observed concentration (Cmax)
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Time to reach Cmax (Tmax)
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)
Title
Assess pharmacokinetics (PK) of epcoritamab
Description
Terminal Elimination Half-Life (t 1/2)
Time Frame
From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have newly diagnosed CD20+ large cell lymphoma. Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: Being age ≥80 years; AND/OR Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy. Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10. Have Ann Arbor Stage II-IV disease. Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment). Have measurable disease as per Lugano criteria. Have acceptable organ function based on baseline bloodwork. Must have fresh (preferred) or archival biopsy material at screening. Exclusion Criteria: Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection. Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy), Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: Major surgery within 4 weeks prior to the first dose of epcoritamab; Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; Live, attenuated vaccines within 30 days prior to initiation of epcoritamab; Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed); Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab. Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture. Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form. Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol. Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS). Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis. Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment. Has suspected active or inadequately treated latent tuberculosis. Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards. Note: Other protocol defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genmab Trial Information
Phone
+4570202728
Ext
+4570202728
Email
clinicaltrials@genmab.com
Facility Information:
Facility Name
UW Cancer Center at ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Schmitt
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Greil
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Thaler
Facility Name
ZNA
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GZA Ziekenhuizen
City
Antwerp
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Lemmens
Facility Name
Institut Jules Bordet
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Maarevoet
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rik Schots
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherida Woel-A-Jin
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caressa Meert
Facility Name
Vitaz
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Van Hende
Facility Name
AZ Turnhout - Campus Sint-Elisabeth
City
Turnhout
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Vrelust
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Belada
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Trneny
Facility Name
Fakultni nemocnice v Motole
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katerina Kopeckova
Facility Name
CHU de Bordeaux - Hôpital Haut-Lévêque
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Xavier Gros
Facility Name
CHU Amiens - Hopital Sud
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Delette
Facility Name
Hopital Claude Huriez - CHRU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Morschhauser
Facility Name
Hopital de la Conception - APHM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Régis Costello
Facility Name
CHU Angers - Hôpital Hôtel Dieu
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome Paillassa
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Gastinne
Facility Name
CHU Tours - Hôpital Bretonneau
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurianne Drieu La Rochelle
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Peyrade
Facility Name
Hôpital Henri Mondor
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Sibon
Facility Name
Hôpital Saint-Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Stocker
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Thieblemont
Facility Name
Jeonbuk National University Hospital
City
Jeonju
State/Province
North Jeolla
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Kwak
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Rok Do
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dok Hyun Yoon
Facility Name
National Cancer Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeon-Seok Eom
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Min Kim
Facility Name
Pratia MCM
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Jurczak
Facility Name
Centrum Medyczne Pratia
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Kwiatek
Facility Name
MICS Centrum Medyczne
City
Toruń
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Chraniuk
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Eva Ginè
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Sureda Balari
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Miguel Bergua Burgues
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Bastos Oreiro
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Jimenez Ubieto
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Cordoba Mascuñano
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Lopez Jimenez
Facility Name
Hospital Universitario Nuestra Señora de Valme
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Rios Herranz
Facility Name
Hospital Universitario Puerta del Mar
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Capote Huelva
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Ortegon Alcaide
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Marsden Hospital - Fulham
City
Fulham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Churchill Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toby Eyre
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David John Lewis
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Lim
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tucker

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

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