Clinical trial · Observational
Italian Real-World Study of Epcoritamab in Relapsed or Refractory DLBCL
Italian Real-world Study on Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT07393204CI-TRIAL-00102731EPKEY_HSRactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Epcoritamab treatment
- description
- Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria
Secondary outcomes (11)
- measure
- Adverse Event according to CTCAE v5.0
- timeFrame
- through study completion, an average of 1 year
- description
- rate and severity of AEs (Adverse Event), AESIs (adverse events of special interest) and SAEs (Serious Adverse Event) according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) * Received at least one dose of epcoritamab * Free and voluntary written informed consent Exclusion Criteria: * Age \< 18 years * Patients who received epcoritamab outside the Cnn program (e.g., open access program, compassionate use, off-label, prospective trials).
References
Publications (0)
Data not yet available
No reference posted for this study.