Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058660) titled 'Real-world Outcomes in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Treated with Epcoritamab in Japan' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Genmab US, Inc.

Condition: Condition - Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 years-old =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 Size - 300

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066647

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