UMIN-CTR Clinical Trial

Public title

Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan

Acronym

J-REALEPCO

Scientific Title

Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan

Scientific Title:Acronym

Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan

Region

Japan

Condition

Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effectiveness of epcoritamab in patients with 3L+ R/R LBCL (including diffuse large B-cell lymphoma [DLBCL], high-grade B-cell lymphoma [HGBCL], primary mediastinal large B-cell lymphoma [PMBCL], and follicular lymphoma [FL] grade 3B) who are treated with epcoritamab in real-world settings in Japan. Additionally, this study also aims to assess patient characteristics, safety information, details on treatment patterns, and healthcare resource utilization (HCRU), in order to investigate treatment outcomes of epcoritamab in real-world settings.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To characterize real-world outcomes among patients with 3L+ R/R LBCL treated with epcoritamab, balanced and similar to the EPCORE NHL-1 aNHL trial cohort (ClinicalTrials.gov: NCT03625037) on key patient characteristics (Target Trial Emulation Cohort).
[Primary Endpoints]
Complete response rate (CRR), best objective response (BOR), overall survival (OS)

Key secondary outcomes

1. To characterize real-world outcomes in Target Trial Emulation Cohort.
[Secondary Endpoint 1]
Real-world duration of response (rwDOR), real-world duration of complete response (rwDOCR), real-world progression-free survival (rwPFS), duration of treatment (DOT), time to next treatment (TTNT)

2. To characterize real-world outcomes in patients with 3L+ R/R LBCL treated with epcoritamab (All Epcoritamab Cohort).
[Secondary Endpoint 2]
CRR, BOR, OS, rwDOR, rwDOCR, rwPFS, DOT, TTNT

3. To characterize adverse events (AEs) of interest in the Target Trial Emulation Cohort and All Epcoritamab Cohort. Selected AEs of interest that require medical attention (i.e., hospitalization, ED visit, clinic visit, or dose delay) include:
a. All grade ICANS, TLS, and PML
b. Grade 2+ CRS
c. Grade 3+ infection, hematological toxicity
[Secondary Endpoint 3]
Proportion of AE of interest (with grade)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Adult patients (>=18 years of age) at the date of initiating epcoritamab (index date)
2. Documented CD20+ mature B-cell neoplasm with the following LBCL subtypes: DLBCL, FL (grade 3b), PMBCL, HGBCL, or other LBCL subtypes
3. R/R disease* and previously treated with 2 or more lines of systemic antineoplastic therapy including at least one anti-CD20 monoclonal antibody-containing therapy
*Relapsed disease is defined as disease that has recurred >=6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy or progressed <6 months since completion of therapy
4. Initiated epcoritamab in the period between May 1, 2024 and Oct 31, 2025 and already initiated epcoritamab at the date of providing consent (or opt-out registration)
5. Provision of the patient's or the legally acceptable representative's informed consent. If the patient is deceased or lost to follow-up, and it is difficult to obtain appropriate consent from the patient or the legally acceptable representative, opt-out registration is permitted, only if the IRB/ IEC permits opt-out, in which the patient or the legally acceptable representative can access the opt-out information and are given the opportunity to refuse the provision of the patient existing information.

Key exclusion criteria

1. Patients who are deemed inappropriate for this study by the investigator
2. Patients who have participated in other clinical trials before epcoritamab and whose medical record data outside the trial period are not allowed to be collected for this study
3. Patients who participated in Epcoritamab-related clinical trials before Oct 31, 2025

Target sample size

300

Name of lead principal investigator

1st name	Laura
Middle name
Last name	Liao

Organization

Genmab US, Inc.

Division name

Center for Outcomes Research, Real World Evidence & Epidemiology

Zip code

08536

Address

777 Scudders Mill Rd, Plainsboro, New Jersey 08536, United States of America

TEL

+1-609-430-2481

Email

llia@genmab.com

Name of contact person

1st name	Yuta
Middle name
Last name	Suzuki

Organization

Mebix, Inc.

Division name

Research Promotion Headquarters

Zip code

105-0001

Address

10F, Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo

TEL

03-4362-4500

Homepage URL

Email

LBCL-chart-review_CRA@mebix.co.jp

Institute

Genmab US, Inc.

Institute

Department

Personal name

Organization

Genmab US, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

United States of America

Co-sponsor

Name of secondary funder(s)

Organization

Non-Profit Organization MINS Research Ethics Committee

Address

5-20-9-401 Mita, Minato-ku, Tokyo

Tel

03-6416-1868

Email

npo-mins@j-irb.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

社会医療法人北楡会 札幌北楡病院 （北海道）
市立札幌病院 （北海道）
独立行政法人国立病院機構 北海道がんセンター （北海道）
岩手医科大学 （岩手県）
国立研究開発法人 国立がん研究センター 中央病院 （東京都）
地方独立行政法人 東京都立病院機構 がん・感染症センター 東京都立駒込病院 （東京都）
市立青梅総合医療センター （東京都）
帝京大学医学部附属病院 （東京都）
昭和医科大学病院 （東京都）
前橋赤十字病院 （群馬県）
地方独立行政法人 埼玉県立病院機構 埼玉県立がんセンター （埼玉県）
日本赤十字社 成田赤十字病院 （千葉県）
国立研究開発法人 国立がん研究センター 東病院 （千葉県）
地方独立行政法人 総合病院 国保旭中央病院 （千葉県）
湘南鎌倉総合病院 （神奈川県）
岐阜大学医学部附属病院 （岐阜県）
独立行政法人国立病院機構 まつもと医療センター （長野県）
順天堂大学医学部附属静岡病院 （静岡県）
山梨大学医学部附属病院 （山梨県）
豊橋市民病院 （愛知県）
関西医科大学附属病院 （大阪府）
地方独立行政法人大阪府立病院機構 大阪国際がんセンター （大阪府）
兵庫県立尼崎総合医療センター （兵庫県）
社会福祉法人恩賜財団済生会滋賀県病院 （滋賀県）
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院 （岡山県）
公立学校共済組合 中国中央病院 （広島県）
広島赤十字・原爆病院 （広島県）
福岡赤十字病院 （福岡県）
宮崎県立延岡病院 （宮崎県）
鹿児島大学大学院医歯学総合研究科 （鹿児島県）

Date of disclosure of the study information

2025

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

06

Month

09

Day

Date of IRB

2025

Year

07

Month

03

Day

Anticipated trial start date

2025

Year

08

Month

16

Day

Last follow-up date

2026

Year

04

Month

30

Day

Date of closure to data entry

2026

Year

07

Month

31

Day

Date trial data considered complete

2026

Year

10

Month

31

Day

Date analysis concluded

2027

Year

10

Month

31

Day

Other related information

This is a multicenter retrospective observational study utilizing medical charts collected from multiple clinical centers in Japan that treat patients with LBCL. In patients who initiated epcoritamab between May 1, 2024, and October 31, 2025, their treatment course will be observed retrospectively from the date of initial LBCL diagnosis, with the data cutoff date set as April 30, 2026.
Study population (i.e., All Epcoritamab Cohort) plans to include 300 patients with 3L+ R/R LBCL treated with epcoritamab at 30 clinical centers in Japan.
Study objectives will be evaluated in (1) All Epcoritamab Cohort and (2) Target Trial Emulation Cohort.
Among (1) All Epcoritamab Cohort, patients who meet the additional eligibility criteria below will also be incorporated in (2) Target Trial Emulation Cohort.

Additional criteria for (2) Target Trial Emulation Cohort.
Inclusion criteria:
1. Failed previous ASCT, or ineligible to ASCT due to age, performance status, comorbidities, and/or insufficient response to prior treatment
2. ECOG PS 0-2 at initiating epcoritamab
3. At least one response assessment after the initiation of epcoritamab
Exclusion criteria:
1. Primary CNS lymphoma or lymphoma with CNS involvement
2. Known past or current malignancy of any type other than inclusion diagnosis, except for any curative cancer with a CR of >2 years duration
3. Known clinically significant cardiovascular disease
4. Known HIV infection
When statistically analyzed, the (2) Target Trial Emulation cohort will be balanced to be similar to the cohort of patients with aNHL enrolled in the EPCORE NHL-1 trial (ClinicalTrials.gov: NCT03625037) based on key patient characteristics.

In addition to the primary and secondary endpoints described above, some items, including demographics, clinical characteristics, treatment regimens before and after epcoritamab, prophylactic treatment and concomitant medication, and LBCL-related HCRU, will be evaluated exploratorily.

Registered date

2025

Year

07

Month

31

Day

Last modified on

2026

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066647