DLBCL - Diffuse Large B Cell Lymphoma
Conditions
Keywords
bendamustine, rituximab, polatuzumab vedotin
Brief summary
Study designobservational, non-interventional, retrospective, multicenter study.
Detailed description
The study focusing on information about the effectiveness and safety of polatuzumab vedotin plus rituximab (± bendamustine) in patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) programme in the period between June 2019 and Feb 2020 in Italy.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with relapsed or refractory DLBCL who received at least 1 dose of polatuzumab vedotin under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy. 2. Age ≥ 18 years at enrolment. 3. Written informed consent (if applicable).
Exclusion criteria
Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate (ORR) | through study completion, an average of 2 years | Effectiveness of polatuzumab vedotin plus rituximab (± bendamustine) in patients with relapsed or refractory DLBCL who have received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy. This value is calculated as the sum of partial (PRR) and complete response rates (CRR) at end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | through study completion, an average of 2 years | is the length of time from either the date of diagnosis or the start of treatment ... |
| Progression Free Survival (PFS) | through study completion, an average of 2 years | the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease |
| disease free survival (DFS) at 6 months | through study completion, an average of 2 years | the time from random assignment to cancer recurrence or death from any cause. |
| frequency distribution of the causes of death | through study completion, an average of 2 years | frequency |
| frequency distribution of the causes of treatment discontinuation | through study completion, an average of 2 years | frequency distribution of the causes of treatment discontinuation |
| Incidence and type of adverse events and severe adverse events | through study completion, an average of 2 years | Incidence |
| Proportion of patients with clinical disease progression | through study completion, an average of 2 years | Proportion |
| Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions | through study completion, an average of 2 years | Proportion of patients with clinical disease progression |
| Best response rate (BRR) | through study completion, an average of 2 years | Best response rate (BRR) |
| Mean treatment duration | through study completion, an average of 2 years | Mean treatment duration |
Countries
Italy
Outcome results
None listed