Non-Hodgkin lymphoma (NHL)
Conditions
Brief summary
Percentage of participants with DLT during the DLT period, Frequency, duration, severity of TEAEs and TRAEs and SAEs, SAEs/AEs leading to discontinuation of AZD4512, Clinically significant alterations in vital signs and abnormal laboratory parameters
Detailed description
Response assessment according to Lugano classification (Cheson et al 2014) for malignant lymphoma: ORR, CR rate, DoR and PFS, Overall survival, Plasma concentrations of AZD4512, total antibody and total unconjugated warhead, Plasma PK parameters of AZD4512, total antibody and total unconjugated warhead but not limited to AUC, Cmax, tmax, Ctrough t1/2, and clearance as data allow, The number and percentage of participants who develop ADAs
Interventions
DRUGAZD4512
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with DLT during the DLT period, Frequency, duration, severity of TEAEs and TRAEs and SAEs, SAEs/AEs leading to discontinuation of AZD4512, Clinically significant alterations in vital signs and abnormal laboratory parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Response assessment according to Lugano classification (Cheson et al 2014) for malignant lymphoma: ORR, CR rate, DoR and PFS, Overall survival, Plasma concentrations of AZD4512, total antibody and total unconjugated warhead, Plasma PK parameters of AZD4512, total antibody and total unconjugated warhead but not limited to AUC, Cmax, tmax, Ctrough t1/2, and clearance as data allow, The number and percentage of participants who develop ADAs | — |
Countries
Italy
Outcome results
None listed