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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05578976




Registration number
NCT05578976
Ethics application status
Date submitted
12/10/2022
Date registered
13/10/2022
Date last updated
4/09/2024

Titles & IDs
Public title
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Scientific title
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
2023-505277-32
Secondary ID [2] 0 0
M20-621
Universal Trial Number (UTN)
Trial acronym
EPCORE DLBCL-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Rituximab
Treatment: Drugs - Vincristine
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Prednisone

Experimental: Epcoritamab and R-CHOP - Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.

Experimental: R-CHOP and Rituximab - Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.


Treatment: Drugs: Epcoritamab
Subcutaneous Injection (SC)

Treatment: Drugs: Cyclophosphamide
Intravenous (IV) Injection

Treatment: Drugs: Rituximab
IV Infusion

Treatment: Drugs: Vincristine
IV Infusion

Treatment: Drugs: Doxorubicin
IV Infusion

Treatment: Drugs: Prednisone
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
Timepoint [1] 0 0
Up to Approximately 46 Months
Secondary outcome [1] 0 0
Number of Participants with PFS
Timepoint [1] 0 0
Up to Approximately 46 Months
Secondary outcome [2] 0 0
Number of Participants with Event-free survival (EFS)
Timepoint [2] 0 0
Up to Approximately 46 Months
Secondary outcome [3] 0 0
Percentage of Participants with Complete Remission (CR)
Timepoint [3] 0 0
On or After to Approximately 28 Weeks
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to Approximately 76 Months
Secondary outcome [5] 0 0
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
Timepoint [5] 0 0
Up to Approximately 46 Months

Eligibility
Key inclusion criteria
* Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
* Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

* DLBCL, Not Otherwise Specified (NOS).
* High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
* T-cell/histiocyte-rich large B-cell lymphoma.
* Epstein Barr virus-positive DLBCL, NOS.
* Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

* Availability of archival or fresh or paraffin embedded tissue at Screening.
* Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
* Has at least one target lesion defined as:

* >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
* Positron emission tomography (PET)-positive on PET-CT scan.
* Laboratory values meeting the criteria laid out in the protocol.
* Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
* Clinically significant cardiovascular disease as per the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2029
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 230072 - Liverpool
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 225683 - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre /ID# 225680 - Clayton
Recruitment hospital [4] 0 0
Austin Health /ID# 225716 - Heidelberg
Recruitment hospital [5] 0 0
The Alfred Hospital /ID# 225999 - Melbourne
Recruitment hospital [6] 0 0
Hollywood Private Hospital /ID# 251837 - Nedlands
Recruitment hospital [7] 0 0
Perth Blood Institute Ltd /ID# 225679 - Nedlands
Recruitment hospital [8] 0 0
Royal Perth Hospital /ID# 226583 - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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Indiana
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Massachusetts
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Michigan
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Mississippi
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Nebraska
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New Jersey
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Namur
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Vlaams-Brabant
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Anderlecht
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Brugge
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Parana
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Sao Paulo
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Brazil
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Rio de Janeiro
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Smolyan
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Jilin
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Primorsko-goranska Zupanija
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Splitsko-dalmatinska Zupanija
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Hovedstaden
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Midtjylland
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Herault
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Isere
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Meurthe-et-Moselle
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Nord
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Paris
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France
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Pays-de-la-Loire
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Pyrenees-Atlantiques
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Rhone
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Somme
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France
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Vendee
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France
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Vienne
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France
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Angers
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France
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Caen
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France
State/province [100] 0 0
Saint-cloud
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Greece
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Attiki
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Thessaloniki
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Hungary
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Gyor-Moson-Sopron
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Hungary
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Hajdu-Bihar
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Hungary
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Somogy
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Hungary
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Tolna
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Hungary
State/province [109] 0 0
Vas
Country [110] 0 0
Hungary
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Budapest
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Hungary
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Szeged
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Israel
State/province [112] 0 0
H_efa
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Israel
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HaMerkaz
Country [114] 0 0
Israel
State/province [114] 0 0
Tel-Aviv
Country [115] 0 0
Israel
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Yerushalayim
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Israel
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Haifa
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Italy
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Foggia
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Italy
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L Aquila
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Italy
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Milano
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Italy
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Torino
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Italy
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Alessandria
Country [122] 0 0
Italy
State/province [122] 0 0
Aviano
Country [123] 0 0
Italy
State/province [123] 0 0
Brescia
Country [124] 0 0
Italy
State/province [124] 0 0
Novara
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Italy
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Palermo
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Italy
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Pisa
Country [127] 0 0
Italy
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Ravenna
Country [128] 0 0
Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka
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Tokyo
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Japan
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Yamagata
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Japan
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Okayama
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Korea, Republic of
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Busan Gwang Yeogsi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea, Republic of
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Gyeongsangnamdo
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Korea, Republic of
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Seoul Teugbyeolsi
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Ulsan Gwang Yeogsi
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Noord-Brabant
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Utrecht
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Zuid-Holland
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Den Haag
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Deventer
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Groningen
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S Hertogenbosch
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New Zealand
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Auckland
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New Zealand
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Canterbury
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Poland
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Pomorskie
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Poland
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Swietokrzyskie
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Poland
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Warminsko-mazurskie
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Poland
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Wielkopolskie
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Portugal
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Braga
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Portugal
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Lisboa
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Portugal
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Porto
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Curitiba
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Manati
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Puerto Rico
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Rio Piedras
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Slovakia
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Bratislavsky Kraj
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Slovakia
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Zilinsky Kraj
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South Africa
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Gauteng
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Murcia
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Skane Lan
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Sweden
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Sodermanlands Lan
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Sweden
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Stockholms Lan
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Sweden
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Vastra Gotalands Lan
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Switzerland
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Aargau
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Switzerland
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Bern
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Switzerland
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Zuerich
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Taiwan
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Kaohsiung
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Taiwan
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Keelung
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Taiwan
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Taichung
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Turkey
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Adana
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Turkey
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Kocaeli
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Turkey
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Malatya
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Turkey
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Samsun
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Turkey
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Yuregir
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United Kingdom
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London, City Of
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United Kingdom
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Norfolk
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United Kingdom
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Birmingham
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United Kingdom
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Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial website
https://clinicaltrials.gov/study/NCT05578976
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
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AbbVie
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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ABBVIE CALL CENTER
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844-663-3742
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[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05578976