Use of LOncastuximab Tesirine in patients with RElapsed/Refractory Diffuse Large B-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) who have progressive disease after CAR T-cell treatment - LORELY

Conditions

Patients affected by relapsed/refractory DLBCL or HGBCL failing CAR T-cell therapy

Brief summary

Overall response rate (ORR) defined as patients in achieving a best overall response of complete response (CR) or partial response (PR) to study treatment, according to the 2014 Lugano Classification

Detailed description

• Progression-free survival (PFS) defined as the time between first dose administration and the first documentation of recurrence or progression by independent central review, or death • Overall survival (OS) defined as the time between first dose administration and death from any cause • Duration of Response (DOR) defined as the time from first documentation of response to recurrence or progression by independent central review, or death, • Frequency and severity of adverse events (AEs) and severeserious adverse events (SAEs), Exploratory • Relationship between blood serum markers of disease and inflammation (LDH, CRP, ferritin) and selected efficacy endpoints • Relationship between changes in plasma ctDNA and selected efficacy endpoints

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGZynlonta 10 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR) defined as patients in achieving a best overall response of complete response (CR) or partial response (PR) to study treatment, according to the 2014 Lugano Classification	—

Secondary

Measure	Time frame
• Progression-free survival (PFS) defined as the time between first dose administration and the first documentation of recurrence or progression by independent central review, or death • Overall survival (OS) defined as the time between first dose administration and death from any cause • Duration of Response (DOR) defined as the time from first documentation of response to recurrence or progression by independent central review, or death, • Frequency and severity of adverse events (AEs) and severeserious adverse events (SAEs), Exploratory • Relationship between blood serum markers of disease and inflammation (LDH, CRP, ferritin) and selected efficacy endpoints • Relationship between changes in plasma ctDNA and selected efficacy endpoints	—

Measure

Time frame

• Progression-free survival (PFS) defined as the time between first dose administration and the first documentation of recurrence or progression by independent central review, or death • Overall survival (OS) defined as the time between first dose administration and death from any cause • Duration of Response (DOR) defined as the time from first documentation of response to recurrence or progression by independent central review, or death, • Frequency and severity of adverse events (AEs) and severeserious adverse events (SAEs), Exploratory • Relationship between blood serum markers of disease and inflammation (LDH, CRP, ferritin) and selected efficacy endpoints • Relationship between changes in plasma ctDNA and selected efficacy endpoints

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Countries

Italy

Outcome results

None listed