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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05409066




Registration number
NCT05409066
Ethics application status
Date submitted
3/06/2022
Date registered
8/06/2022

Titles & IDs
Public title
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Scientific title
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
Secondary ID [1] 0 0
2021-000169-34
Secondary ID [2] 0 0
M20-638
Universal Trial Number (UTN)
Trial acronym
EPCORE FL-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL) 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

Experimental: Epcoritamab Dose A in Combination With R2 - Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Experimental: Epcoritamab Dose B in Combination With R2 - Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.

Active comparator: Lenalidomide and Rituximab (R2) - Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).


Treatment: Drugs: Epcoritamab
Subcutaneous Injection

Treatment: Drugs: Rituximab
Intravenous Infusion

Treatment: Drugs: Lenalidomide
Oral Capsules
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 approximately 5 years
Secondary outcome [1] 0 0
Percentage of Participants Achieving Complete Response (CR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 8 years from randomization
Secondary outcome [3] 0 0
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
Timepoint [3] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
* Participant has:

* Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
* >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
* Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
* Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
* Eligible to receive R2 per investigator determination.
* Estimated Creatinine Clearance (CrCl) >= 50 mL/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Documented refractoriness to lenalidomide.
* Have lenalidomide exposure within 12 months prior to randomization.

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
20/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 239272 - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital /ID# 239093 - Kingswood
Recruitment hospital [3] 0 0
Townsville University Hospital /ID# 231124 - Douglas
Recruitment hospital [4] 0 0
Peninsula Private Hospital /ID# 238796 - Frankston
Recruitment hospital [5] 0 0
Fiona Stanley Hospital /ID# 231122 - Murdoch
Recruitment hospital [6] 0 0
Royal Perth Hospital /ID# 230456 - Perth
Recruitment hospital [7] 0 0
Hollywood Private Hospital /ID# 251789 - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Montana
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New York
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Oklahoma
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Utah
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Virginia
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Argentina
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Ciudad Autonoma De Buenos Aires
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Santa Fe
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Hainaut
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Anderlecht
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Caen
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Bayern
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Hessen
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Thueringen
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Bamberg
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Berlin
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Essen
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Trier
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Ioannina
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Greece
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Somogy
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H_efa
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HaMerkaz
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Tel-Aviv
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Torino
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Bari
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Italy
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Italy
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Fukuoka
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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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Kagoshima
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Kanagawa
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Kyoto
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Mie
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Japan
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Nagano
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Osaka
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Tokyo
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Japan
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Yamagata
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Deventer
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Groningen
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Auckland
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Manati
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Gauteng
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Barcelona
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Ticino
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Kaohsiung
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Taichung
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Tainan
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Turkey
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Ankara
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Antalya
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Samsun
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United Kingdom
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Devon
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United Kingdom
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Greater London
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United Kingdom
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Oxfordshire
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United Kingdom
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Scotland
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United Kingdom
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West Yorkshire
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United Kingdom
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Birmingham
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United Kingdom
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Colchester
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

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.

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/NCT05409066