Study designobservational, non-interventional, retrospective, multicenter study.
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.
Study Type
OBSERVATIONAL
Enrollment
100
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy
Casa Sollievo della Sofferenza - Reparto di Oncoematologia
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria- Policlinico di Bari
Bari, Italy
overall response rate (ORR)
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.
Time frame: through study completion, an average of 2 years
Overall Survival (OS)
is the length of time from either the date of diagnosis or the start of treatment ...
Time frame: through study completion, an average of 2 years
Progression Free Survival (PFS)
the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease
Time frame: through study completion, an average of 2 years
disease free survival (DFS) at 6 months
the time from random assignment to cancer recurrence or death from any cause.
Time frame: through study completion, an average of 2 years
frequency distribution of the causes of death
frequency
Time frame: through study completion, an average of 2 years
Mean treatment duration
Mean treatment duration
Time frame: through study completion, an average of 2 years
Incidence and type of adverse events and severe adverse events
Incidence
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Ospedale Oncologico Armando Businco
Cagliari, Italy
Ospedale Maggiore della Carità
Novara, Italy
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo, Italy
CORE IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Azienda Ospedaliera Santa Maria - SC di Oncoematologia
Terni, Italy
ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia
Treviso, Italy
Time frame: through study completion, an average of 2 years
Proportion of patients with clinical disease progression
Proportion
Time frame: through study completion, an average of 2 years
Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions
Proportion of patients with clinical disease progression
Time frame: through study completion, an average of 2 years
Best response rate (BRR)
Best response rate (BRR)
Time frame: through study completion, an average of 2 years
frequency distribution of the causes of treatment discontinuation
frequency distribution of the causes of treatment discontinuation
Time frame: through study completion, an average of 2 years