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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06508658




Registration number
NCT06508658
Ethics application status
Date submitted
11/07/2024
Date registered
18/07/2024

Titles & IDs
Public title
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scientific title
A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Secondary ID [1] 0 0
2024-510965-41-00
Secondary ID [2] 0 0
M22-128
Universal Trial Number (UTN)
Trial acronym
EPCORE DLBCL-4
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 - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm A: Epcoritamab Plus Lenalidomide (E-Len) - Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).

Experimental: Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx) - Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)


Treatment: Drugs: Epcoritamab
Subcutaneous Injection

Treatment: Drugs: Rituximab
Intravenous (IV) Infusion

Treatment: Drugs: Lenalidomide
Oral Capsule

Treatment: Drugs: Oxaliplatin
IV Infusion

Treatment: Drugs: Gemcitabine
IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 4 Years
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve Complete response (CR)
Timepoint [1] 0 0
Up to 4 Years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 4 Years
Secondary outcome [3] 0 0
Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
Timepoint [3] 0 0
Up to 4 Years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group Performance status score of 0 to 2.
* Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
* Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
* . Participant must meet at least 1 of the following criteria:

* Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to ASCT.
* Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
* Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

* Unable to receive CAR-T therapy due to fitness and/or comorbidity.
* Lymphocyte apheresis failure.
* Unwilling to receive CAR-T therapy.
* Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
* Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
* Must have measurable disease.
* Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
* History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
* Documented refractoriness to lenalidomide.

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
13/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital /ID# 265312 - Canberra
Recruitment hospital [2] 0 0
Wollongong Hospital /ID# 244646 - Wollongong
Recruitment hospital [3] 0 0
Toowoomba Hospital /ID# 263243 - Toowoomba
Recruitment hospital [4] 0 0
Monash Medical Centre /ID# 262783 - Clayton
Recruitment hospital [5] 0 0
Royal Perth Hospital /ID# 243790 - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4350 - Toowoomba
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles-Capitale
Country [5] 0 0
Belgium
State/province [5] 0 0
Hainaut
Country [6] 0 0
Belgium
State/province [6] 0 0
Namur
Country [7] 0 0
Belgium
State/province [7] 0 0
Vlaams-Brabant
Country [8] 0 0
Belgium
State/province [8] 0 0
West-Vlaanderen
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Plovdiv
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Varna
Country [12] 0 0
Croatia
State/province [12] 0 0
Grad Zagreb
Country [13] 0 0
Croatia
State/province [13] 0 0
Splitsko-dalmatinska Zupanija
Country [14] 0 0
France
State/province [14] 0 0
Indre-et-Loire
Country [15] 0 0
France
State/province [15] 0 0
Provence-Alpes-Cote-d Azur
Country [16] 0 0
France
State/province [16] 0 0
Pyrenees-Atlantiques
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Strasbourg
Country [19] 0 0
Greece
State/province [19] 0 0
Attiki
Country [20] 0 0
Greece
State/province [20] 0 0
Athens
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyor-Moson-Sopron
Country [22] 0 0
Hungary
State/province [22] 0 0
Hajdu-Bihar
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Japan
State/province [24] 0 0
Ehime
Country [25] 0 0
Japan
State/province [25] 0 0
Fukuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Fukushima
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Kagoshima
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Yamanashi
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Busan Gwang Yeogsi
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggido
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeongsangbugdo
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Gyeongsangnamdo
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Jeonranamdo
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul Teugbyeolsi
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Ulsan Gwang Yeogsi
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland
Country [40] 0 0
Poland
State/province [40] 0 0
Malopolskie
Country [41] 0 0
Poland
State/province [41] 0 0
Wielkopolskie
Country [42] 0 0
Portugal
State/province [42] 0 0
Lisboa
Country [43] 0 0
Portugal
State/province [43] 0 0
Porto
Country [44] 0 0
Romania
State/province [44] 0 0
Bucuresti
Country [45] 0 0
Romania
State/province [45] 0 0
Cluj
Country [46] 0 0
Romania
State/province [46] 0 0
Iasi
Country [47] 0 0
Romania
State/province [47] 0 0
Bucharest
Country [48] 0 0
Serbia
State/province [48] 0 0
Beograd
Country [49] 0 0
Serbia
State/province [49] 0 0
Nisavski Okrug
Country [50] 0 0
Serbia
State/province [50] 0 0
Vojvodina
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taipei
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taichung
Country [53] 0 0
Taiwan
State/province [53] 0 0
Tainan

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?
Genmab is committed to responsible data sharing regarding the clinical trials we sponsor. 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.


Results not provided in https://clinicaltrials.gov/study/NCT06508658