Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Brief summary
Incidence and severity of TEAEs (TEAE, treatment-emergent adverse event)
Detailed description
• Tafasitamab serum concentrations after 3 (Ctrough and Cmax) and 12 (Ctrough) treatment cycles, • Best Objective Response Rate (ORR) by Investigator assessment up to treatment Cycle 12 based on Cheson et al. (2007), • Duration of Response (DoR) by Investigator assessment based on Cheson et al. (2007), • Progression-Free Survival (PFS) by Investigator assessment based on Cheson et al. (2007), • Number and percentage of patients developing anti- tafasitamab antibodies up to treatment Cycle 12
Interventions
Sponsors
Incyte Corp., Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of TEAEs (TEAE, treatment-emergent adverse event) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Tafasitamab serum concentrations after 3 (Ctrough and Cmax) and 12 (Ctrough) treatment cycles, • Best Objective Response Rate (ORR) by Investigator assessment up to treatment Cycle 12 based on Cheson et al. (2007), • Duration of Response (DoR) by Investigator assessment based on Cheson et al. (2007), • Progression-Free Survival (PFS) by Investigator assessment based on Cheson et al. (2007), • Number and percentage of patients developing anti- tafasitamab antibodies up to treatment Cycle 12 | — |
Countries
Austria, Czechia, Italy, Poland, Spain
Outcome results
None listed