Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)
Conditions
Interventions
None listed
Sponsors
Genmab US, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactYuta Suzuki
Mebix, Inc. Research Promotion Headquarters
Outcome results
None listed