UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058660 |
|---|---|
| Receipt number | R000066647 |
| Scientific Title | Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/31 11:40:07 |
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Basic information
Public title
Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan
Acronym
Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan
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
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
Objectives
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
Assessment
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
llia@genmab.com
Public contact
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
LBCL-chart-review_CRA@mebix.co.jp
Sponsor or person
Institute
Genmab US, Inc.
Institute
Department
Personal name
Funding Source
Organization
Genmab US, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
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.
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066647
