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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epcoritamab treatment | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event according to CTCAE v5.0 | 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) | through study completion, an average of 1 year |
| Incidence and Severity of Cytokine Release Syndrome (CRS) |
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Inclusion Criteria:
Exclusion Criteria:
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The study is expected to include approximately 150 patients. 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria |
| through study completion, an average of 1 year |
| Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | ICANS graded according to ASTCT ICANS grading criteria (ICE score) | through study completion, an average of 1 year |
| Complete Response rate | 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 | through study completion, an average of 1 year |
| Duration of Response | 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. | through study completion, an average of 1 year |
| Duration of Complete Response | DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier. | through study completion, an average of 1 year |
| Progression Free Survival | 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. | through study completion, an average of 1 year |
| Overall Survival | OS is defined as the time from the start of epcoritamab treatment to death | through study completion, an average of 1 year |
| Time To Next Treatment | TTNT is defined as duration from treatment initiation to the start of new anti-lymphoma therapy or death due to PD, whichever occurs earlier | through study completion, an average of 1 year |
| Duration of Treatment | 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. | through study completion, an average of 1 year |
| Health Care Resource Utilization (HCRU) | 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 | through study completion, an average of 1 year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |