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
Study Type
OBSERVATIONAL
Enrollment
150
IRCCS Ospedale San Raffaele
Milan, Italy
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
Time frame: 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
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)
Time frame: through study completion, an average of 1 year
Incidence and Severity of Cytokine Release Syndrome (CRS)
Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 1 year
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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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Overall Survival
OS is defined as the time from the start of epcoritamab treatment to death
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: through study completion, an average of 1 year