ClinicalTrials.gov

History of Changes for Study: NCT03625037
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1)
Latest version (submitted May 6, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 9, 2018 None (earliest Version on record)
2 August 14, 2018 Study Status
3 September 13, 2018 Study Status and Contacts/Locations
4 September 27, 2018 Contacts/Locations and Study Status
5 January 7, 2019 Contacts/Locations, Study Status and Eligibility
6 January 14, 2019 Contacts/Locations and Study Status
7 February 26, 2019 Contacts/Locations and Study Status
8 April 12, 2019 Study Status and Contacts/Locations
9 July 19, 2019 Study Status and Contacts/Locations
10 August 20, 2020 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility and Sponsor/Collaborators
11 January 8, 2021 Contacts/Locations, Study Status and Study Design
12 February 11, 2021 Contacts/Locations, Study Status, Study Identification, Eligibility and Study Design
13 July 27, 2021 Study Status and Contacts/Locations
14 June 17, 2022 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status, Study Description, Eligibility and Study Identification
15 October 18, 2022 Outcome Measures, Study Description, Study Status, Study Identification, Contacts/Locations, Eligibility and Study Design
16 February 7, 2023 Study Status
17 February 23, 2023 Study Status
18 March 27, 2023 Outcome Measures, Study Status, Study Identification, Study Description, Eligibility and Conditions
19 May 25, 2023 Study Status, References, Arms and Interventions and Study Description
20 May 30, 2023 Study Status and Study Identification
21 June 27, 2023 Study Status, Contacts/Locations and Study Design
22 August 7, 2023 Contacts/Locations, Study Status and Study Identification
23 January 2, 2024 Study Status
24 February 14, 2024 Outcome Measures, Contacts/Locations, Study Description, Study Status, Eligibility, Arms and Interventions, Study Design and Conditions
25 March 4, 2024 Study Status and Study Identification
26 March 25, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
27 April 4, 2024 Study Status
28 May 6, 2024 Study Status and Study Identification
Comparison Format:

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Changes (Merged) for Study: NCT03625037
March 4, 2024 (v25) -- March 25, 2024 (v26)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: GCT3013-01
Brief Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1)
Official Title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Secondary IDs: 2017-001748-36 [EudraCT Number]
NL64317.078.17 [Registry Identifier: CCMO]
241053 [IRAS ID; UK Research Summaries Database]
2023-504802-12-00 [Registry Identifier: EU CTIS]
Open or close this module Study Status
Record Verification: March 2024
Overall Status: Recruiting Active, not recruiting
Study Start: June 26, 2018
Primary Completion: January March 2025 [Anticipated]
Study Completion: April January 2029 [Anticipated]
First Submitted: June 7, 2018
First Submitted that
Met QC Criteria:
August 9, 2018
First Posted: August 10, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
March 4 25, 2024
Last Update Posted: March 5 26, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Genmab
Responsible Party: Sponsor
Collaborators: AbbVie
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

  • The dose schedule for epcoritamab
  • The side effects seen with epcoritamab
  • What the body does with epcoritamab once it is administered
  • What epcoritamab does to the body once it is administered
  • How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

The trial consists of 3 parts:

  • a dose-escalation part [Phase 1, first-in-human (FIH)]
  • an expansion part (Phase 2a)
  • a dose-optimization part (OPT) (Phase 2a)

The trial time for each participant depends on which trial part the participant enters:

  • For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
  • For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

All participants will receive active drug, and no participants will be given placebo.

Detailed Description:

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma.

In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)

All participants will receive epcoritamab at the RP2D.

Open or close this module Conditions
Conditions: DLBCL
High-grade B-cell Lymphoma (HGBCL)
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
FL
MCL
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 826 [Anticipated] 666 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Epcoritamab
Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Biological: Epcoritamab
Administered as specified in the treatment arm.
Other Names:
  • GEN3013
  • DuoBody®-CD3xCD20
  • EPKINLY™
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Dose-Escalation: Dose Limiting Toxicity (DLT)
[ Time Frame: During the first cycle (28 days) in each Dose-OPT Part DLBCL, FL and MCL ]

To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
2. Dose-Escalation: Number of Participants with Adverse Events (AEs)
[ Time Frame: From first dose until the end of the safety follow-up period (Up to 1 year) ]

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
3. Expansion and Dose-OPT MCL: Overall Response Rate (ORR)
[ Time Frame: Up to 1.5 years ]

ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria as assessed by independent review committee (IRC).
4. Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
[ Time Frame: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL) ]

CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Secondary Outcome Measures:
1. Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
[ Time Frame: Up to 1 year ]

Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
2. Dose-Escalation: DOR
[ Time Frame: Up to 1 year ]

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier as assessed by the investigator.
3. Expansion: DOR
[ Time Frame: Up to 1.5 years ]

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by IRC.
4. Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
[ Time Frame: Up to 1.5 year ]

Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
5. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
[ Time Frame: Up to 1.5 years ]

CRS will be graded based on ASTCT criteria.
6. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
[ Time Frame: Up to 1.5 years ]

CRS will be graded based on ASTCT criteria.
7. Dose-OPT DLBCL and FL: ORR
[ Time Frame: Up to 1.5 years ]

ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
8. Dose-OPT DLBCL and FL: CR Rate
[ Time Frame: Up to 1.5 years ]

CR rate is defined as the percentage of participants with CR assessed by investigator.
9. Dose-OPT DLBCL and FL: Duration of CR (DoCR)
[ Time Frame: Up to 1.5 years ]

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
10. Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
[ Time Frame: Up to 1.5 years ]

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
11. Dose-OPT DLBCL and FL: DLT
[ Time Frame: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL) ]

To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
12. Dose-OPT MCL: Time to Complete Response (TTCR)
[ Time Frame: Up to 1.5 years ]

TTCR is defined as the time from Day 1 of Cycle 1 to first documentation of complete response based on Lugano criteria and LYRIC as assessed by IRC.
13. Dose-OPT DLBCL, FL and MCL: DOR
[ Time Frame: Up to 1.5 years ]

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
14. Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab
[ Time Frame: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days) ]

15. Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
[ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years ]

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria assessed by IRC.
16. Expansion and Dose-OPT MCL: CR Rate
[ Time Frame: Up to 1.5 years ]

CR rate is defined as the percentage of participants with CR based on Lugano criteria as assessed by IRC.
17. Expansion and Dose-OPT MCL: DoCR
[ Time Frame: Up to 1.5 years ]

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria as assessed by IRC.
18. Expansion and Dose-OPT MCL: ORR
[ Time Frame: Up to 1.5 years ]

ORR is defined as the percentage of participants achieving CR or PR based on lymphoma response to immunomodulatory therapy criteria (LYRIC) as assessed by IRC.
19. Expansion and Dose-OPT MCL: Time to Response (TTR)
[ Time Frame: Up to 1.5 years ]

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria as assessed by IRC.
20. Expansion and Dose-OPT MCL: CR Rate
[ Time Frame: Up to 1.5 years ]

CR rate is defined as the percentage of participants with CR based on LYRIC as assessed by IRC.
21. Expansion and Dose-OPT MCL: PFS
[ Time Frame: Up to 1.5 years ]

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC assessed by IRC.
22. Expansion and Dose-OPT MCL: DOR
[ Time Frame: Up to 1.5 years ]

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC assessed by IRC.
23. Expansion and Dose-OPT MCL: DoCR
[ Time Frame: Up to 1.5 years ]

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC as assessed by IRC.
24. Expansion and Dose-OPT MCL: TTR
[ Time Frame: Up to 1.5 years ]

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC as assessed by IRC.
25. Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
[ Time Frame: Up to 7 years and 6 months ]

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
26. Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
[ Time Frame: Up to 1.5 years ]

MRD is defined as percentage of participants with at least 1 MRD negative result.
27. All Parts: Number of Participants with CRS Events
[ Time Frame: Up to Day 1 of Cycle 12 (Cycle length=28 days) ]

CRS will be graded based on ASTCT criteria.
28. All Parts: Immunophenotyping for Absolute T-cell and B-cell
[ Time Frame: Up to Day 1 of Cycle 12 (Cycle length=28 days) ]

Number of cells will be reported for absolute T-cells and B-cells.
29. All Parts: T-Cell Activation and Exhaustion Marker
[ Time Frame: Up to 7 years and 6 months ]

T-Cell Activation and Exhaustion Marker (CD69, CD25, and PD-1) will be measured using flow cytometry.
30. All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)
[ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]

31. All Parts: Area under Curve (AUC) of Epcoritamab
[ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]

32. All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab
[ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]

33. All Parts: Time to Reach Cmax of Epcoritamab
[ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]

34. All Parts: Half Life of Epcoritamab (t1/2)
[ Time Frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days) ]

35. All Parts: Number of Participants with Anti-drug Antibody (ADA)
[ Time Frame: Up to 7 years and 6 months ]

Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.
36. All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
[ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years ]

TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.
37. All Parts: Overall survival (OS)
[ Time Frame: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years ]

OS is defined as the time from Day 1 of Cycle 1 to death.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Main Inclusion Criteria - Escalation Part (recruitment completed)

  • Documented CD20+ mature B-cell neoplasm
    1. DLBCL - de novo or transformed
    2. HGBCL
    3. PMBCL
    4. FL
    5. MCL
    6. SLL
    7. MZL (nodal, extranodal or mucosa associated)
  • Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
  • Participants must have measurable disease by CT, MRI or Positron emission tomography-Computed tomography (PET-CT) scan
  • Acceptable renal function.
  • Acceptable liver function.

Main Inclusion Criteria - Expansion & Dose-OPT Parts

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
  • DLBCL, de novo or transformed (including double hit or triple hit).
  • PMBCL
  • FL grade 3B
  • Histologic confirmed FL
  • MZL
  • SLL
  • MCL (prior BTKi or intolerant to BTKi)
  • At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen.
  • Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities.
  • At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.

Main Exclusion Criteria - All Parts

  • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
  • Known past or current malignancy other than inclusion diagnosis.
  • AST, and/or ALT >3 × upper limit of normal.
  • Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
  • Estimated Creatinine clearance (CrCl) <45 mL/min.
  • Known clinically significant cardiovascular disease.
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration.
  • Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue.
  • Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation.
  • Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Participants with evidence of prior HBV but who are PCR-negative are permitted in
  • Known human immunodeficiency virus (HIV) infection.
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF).
  • Pregnancy or breast feeding.
  • Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant.
  • Contraindication to all uric acid lowering agents.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Open or close this module Contacts/Locations
Central Contact Person: Genmab Trial Information
Telephone: +45 70202728
Email: clinicaltrials@genmab.com
Study Officials: Study Official
Study Director
Genmab
Locations: United States, Arizona
Arizona Mayo Clinic
[Recruiting]
Phoenix, Arizona, United States, 85054
United States, California
University of California at San Francisco
[Recruiting]
San Francisco, California, United States, 94117
United States, Colorado
Colorado Blood Cancer Institute
[Recruiting]
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
[Recruiting]
Tampa, Florida, United States, 33612
United States, Georgia
Northside Hospital- The Blood Marrow Transplant Group
[Withdrawn]
Atlanta, Georgia, United States, 30309
United States, Iowa
University of Iowa Hospital and Clinics
[Recruiting]
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Medical Center
[Recruiting]
New Orleans, Louisiana, United States, 70121
United States, Michigan
University of Michigan
[Recruiting]
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Institute
[Recruiting]
Detroit, Michigan, United States, 48334
United States, Nebraska
University of Nebraska Medical Center
[Recruiting]
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack Meridian Health
[Recruiting]
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Levine Cancer institute/ Atrium Health
[Withdrawn]
Charlotte, North Carolina, United States, 28204
United States, Ohio
The Cleveland Clinic Foundation
[Recruiting]
Cleveland, Ohio, United States, 44195
United States, Oregon
OHSU Knight Cancer Institute
[Recruiting]
Portland, Oregon, United States, 97210
United States, Pennsylvania
Hillman Cancer Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Rhode Island Hospital
[Recruiting]
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
[Recruiting]
Charleston, South Carolina, United States, 29425
Prisma Health- Upstate
[Withdrawn]
Greenville, South Carolina, United States, 29605
United States, Texas
UT Southwestern
[Recruiting]
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
[Withdrawn]
Madison, Wisconsin, United States, 53705
Australia
Monash Health
[Recruiting]
Clayton, Australia
Concord Hospital
[Recruiting]
Concord, Australia
St. Vincent Hospital
[Recruiting]
Fitzroy, Australia
Integrated Clinical Oncology Network Pty Ltd (ICON)
[Recruiting]
Herston, Australia
Royal Brisbane and Women's Hospital
Herston, Australia
Royal Hobart Hospital RHH
[Recruiting]
Hobart, Australia
St. George Hospital
[Recruiting]
Kogarah, Australia
Cabrini Hospital
[Recruiting]
Malvern, Australia
Sir Charles Gairdner Hospital
[Recruiting]
Nedlands, Australia
Gold Coast Hospital
[Recruiting]
Southport, Australia
St George Westmead Hospital
[Recruiting]
Sydney, Australia
Canada
Tom Baker Cancer Care
[Recruiting]
Calgary, Canada
Toronto-Sunnybrook Regional Cancer Ctr
[Completed]
Toronto, Canada
Denmark
Rigshospitalet
[Recruiting]
Copenhagen, Denmark
Odense University Hospital
[Recruiting]
Odense, Denmark, 5000 C
Vejle Hospital
[Recruiting]
Vejle, Denmark
Finland
Helsinki University Hospital
[Recruiting]
Helsinki, Finland
Kuopio University Hospital
[Recruiting]
Kuopio, Finland
Tampere University Hospital
[Recruiting]
Tampere, Finland
France
Hopital Henri Mondor
[Recruiting]
Créteil, France
Hopital Huriez-CHRU Lille
[Withdrawn]
Lille, France
CHU Montpellier
[Recruiting]
Montpellier, France
Hospital Saint-Louis
[Recruiting]
Paris, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
[Recruiting]
Pierre-Bénite, France
Centre Henri Becquerel
[Recruiting]
Rouen cedex, France
CHU de Tours-Hopital Bretonneau
[Recruiting]
Tours, France
Institut Gustave Roussy
[Withdrawn]
Villejuif, France
Germany
Charite - Universitaetsmedizin Berlin
[Recruiting]
Berlin, Germany
Klinik fur Innere Medizin Hamatologie and Onkologie
[Recruiting]
Berlin, Germany
Universitaetsklinikum Koeln
[Recruiting]
Cologne, Germany
Universitaetsklinikum Essen
[Recruiting]
Essen, Germany
Johannes Gutenberg University
[Recruiting]
Mainz, Germany
Der Universität Munchen Medizinische Klinik III LMU
[Recruiting]
München, Germany
Italy
Ao Ss Antonio E Biagio Alessandria
[Recruiting]
Alessandria, Italy
Policlinico S. Orsola-Ematologia LA Seragnoli
[Recruiting]
Bologna, Italy
Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
[Recruiting]
Candiolo, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
[Recruiting]
Meldola, Italy
IRCCS Ospedale San Raffaele
[Recruiting]
Milan, Italy
Korea, Republic of
Dong-A University Hospital
[Active, not recruiting]
Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
[Active, not recruiting]
Daegu, Korea, Republic of
National Cancer Center
[Active, not recruiting]
Goyang-si, Korea, Republic of
Chonbuk National University Hospital
[Active, not recruiting]
Jeonju, Korea, Republic of
Seoul National University Bundang Hospital
[Active, not recruiting]
Seongnam-si, Korea, Republic of
Asan Medical Center
[Active, not recruiting]
Seoul, Korea, Republic of
Samsung Medical Center
[Active, not recruiting]
Seoul, Korea, Republic of
Seoul National University Hospital
[Active, not recruiting]
Seoul, Korea, Republic of
Severance Hospital, Yonsei University
[Completed]
Seoul, Korea, Republic of
Netherlands
VU University Medical Center
[Recruiting]
Amsterdam, Netherlands
Maastricht University Medical Center
[Active, not recruiting]
Maastricht, Netherlands, 6229 HX
Erasmus MC Cancer Institute
[Recruiting]
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
[Recruiting]
Utrecht, Netherlands
Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
[Recruiting]
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne
[Recruiting]
Gdańsk, Poland
Pratia-McM
[Recruiting]
Kraków, Poland
Uniwersytet Medyczny w Lublinie
[Withdrawn]
Lublin, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
[Recruiting]
Słupsk, Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute
[Recruiting]
Warszawa, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
[Recruiting]
Wrocław, Poland
Singapore
National University Hospital
[Recruiting]
Singapore, Singapore
Singapore General Hospital
[Recruiting]
Singapore, Singapore
Spain
Hospital Germans Trias i Pujol
[Recruiting]
Badalona, Spain
Hospital Universitario Vall dHebron
[Recruiting]
Barcelona, Spain
Institut Catala de Oncologia
[Recruiting]
Barcelona, Spain
Hospital Universitario Fundacin Jimnez Daz
[Recruiting]
Madrid, Spain
Spain, Navarra
Clinica Universidad de Navarra
[Recruiting]
Pamplona, Navarra, Spain, 31008
Sweden
Skåne University Hospital
[Recruiting]
Lund, Sweden
Karolinska University Hospital Huddinge
[Recruiting]
Stockholm, Sweden
Akademiska sjukhuset Uppsala University Hospital
[Recruiting]
Uppsala, Sweden
United Kingdom
University Hospital of Wales
[Withdrawn]
Cardiff, United Kingdom
United Kingdom
The Christie NHS Foundation Trust
[Recruiting]
Manchester, United Kingdom
Plymouth University School of Medicine- Derriford Hospital
[Recruiting]
Plymouth, United Kingdom
University Hospital Southampton NHS Foundation Trust
[Active, not recruiting]
Southampton, United Kingdom
Royal Marsden NHS Foundation Trust
[Recruiting]
Sutton, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: [Study Results] Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22. PubMed 36548927
Links:
Available IPD/Information:

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