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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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Nebraska
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New Jersey
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New Mexico
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Niederoesterreich
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Salzburg
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Hainaut
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Liege
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Anderlecht
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Brugge
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Parana
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Rio de Janeiro
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Plovdiv
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Sofia
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Jilin
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Liaoning
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Shanxi
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Tianjin
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Zhejiang
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Grad Zagreb
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Primorsko-goranska Zupanija
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Splitsko-dalmatinska Zupanija
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Croatia
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Slavonski Brod
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Brno-mesto
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Hradec Kralove
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Ostrava-mesto
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Prague
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Praha
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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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Vendee
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France
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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
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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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Tolna
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Hungary
State/province [109] 0 0
Vas
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Hungary
State/province [110] 0 0
Budapest
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Hungary
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Szeged
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Israel
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H_efa
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Israel
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HaMerkaz
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Israel
State/province [114] 0 0
Tel-Aviv
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Israel
State/province [115] 0 0
Yerushalayim
Country [116] 0 0
Israel
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Haifa
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Italy
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Emilia-Romagna
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Italy
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Foggia
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Italy
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Milano
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Italy
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Napoli
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Italy
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Piemonte
Country [122] 0 0
Italy
State/province [122] 0 0
Pordenone
Country [123] 0 0
Italy
State/province [123] 0 0
Reggio Emilia
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Italy
State/province [124] 0 0
Torino
Country [125] 0 0
Italy
State/province [125] 0 0
Alessandria
Country [126] 0 0
Italy
State/province [126] 0 0
Bari
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Italy
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Brescia
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Italy
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Novara
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Italy
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Palermo
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Italy
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Pisa
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Italy
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Ravenna
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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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Kanagawa
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Miyagi
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Okayama
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Osaka
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Tokyo
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Yamagata
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Korea, Republic of
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Busan Gwang Yeogsi
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Gyeonggido
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Overijssel
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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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Auckland
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Portugal
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Braga
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Lisboa
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Bern
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Taichung
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Country [202] 0 0
Turkey
State/province [202] 0 0
Malatya
Country [203] 0 0
Turkey
State/province [203] 0 0
Samsun
Country [204] 0 0
Turkey
State/province [204] 0 0
Trabzon
Country [205] 0 0
Turkey
State/province [205] 0 0
Yuregir
Country [206] 0 0
United Kingdom
State/province [206] 0 0
England
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Norfolk
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Birmingham
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Edinburgh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.