Refractory Diffuse Large B-Cell Lymphoma, Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Conditions
Keywords
DLBCL, relapsed, refractory
Brief summary
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
Interventions
None listed
Sponsors
Andrés José Maria Ferreri
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 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 | Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event according to CTCAE v5.0 | through study completion, an average of 1 year | 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) |
| Incidence and Severity of Cytokine Release Syndrome (CRS) | through study completion, an average of 1 year | Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria |
| Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | through study completion, an average of 1 year | ICANS graded according to ASTCT ICANS grading criteria (ICE score) |
| Complete Response rate | through study completion, an average of 1 year | CR rate defined as the proportion of patients with CR, according to Lugano Criteria at 1, 2, 3, 6, 9 and 12 months since treatment start |
| Duration of Response | through study completion, an average of 1 year | DoR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier. |
| Duration of Complete Response | through study completion, an average of 1 year | DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier. |
| Progression Free Survival | through study completion, an average of 1 year | PFS is defined as the time from the start of the treatment to first documented PD or death due to any cause, whichever occurs earlier. |
| Overall Survival | through study completion, an average of 1 year | OS is defined as the time from the start of epcoritamab treatment to death |
| Time To Next Treatment | through study completion, an average of 1 year | TTNT is defined as duration from treatment initiation to the start of new anti-lymphoma therapy or death due to PD, whichever occurs earlier |
| Duration of Treatment | through study completion, an average of 1 year | Duration of Treatment (DoT) is defined as the time from the start of the treatment to discontinuation or death due to any cause, whichever occurs earlier. |
| Health Care Resource Utilization (HCRU) | through study completion, an average of 1 year | Health Care Resource Utilization (HCRU) as number and duration of unplanned hospitalizations during treatment and follow-up, number of hematological visits, load of diagnostic exams |
Countries
Italy
Outcome results
None listed