Clinical trial NCT06734078: An Italian Multicenter Retrospective Observational Study to Assess the Clinical Characteristics and the Outcome of Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin Plus Rituximab (± Bendamustine) Under Named Patient Programme
Official title: An Italian Multicenter Retrospective Observational Study to Assess the Clinical Characteristics and the Outcome of Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin Plus Rituximab (± Bendamustine) Under Named Patient Programme
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Keywords: bendamustine
rituximab
polatuzumab vedotin
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DLBCL 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: disease free survival (DFS) at 6 months
timeFrame: through study completion, an average of 2 years
measure: frequency distribution of the causes of death
timeFrame: through study completion, an average of 2 years
measure: Mean treatment duration
timeFrame: through study completion, an average of 2 years
measure: Incidence and type of adverse events and severe adverse events
timeFrame: through study completion, an average of 2 years
measure: Proportion of patients with clinical disease progression
timeFrame: through study completion, an average of 2 years
measure: Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions
timeFrame: through study completion, an average of 2 years
measure: Best response rate (BRR)
timeFrame: through study completion, an average of 2 years
measure: frequency distribution of the causes of treatment discontinuation
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza - Reparto di Oncoematologia
state: Foggia
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria- Policlinico di Bari
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
city: Cagliari
country: Italy
facility: Ospedale Oncologico Armando Businco
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
city: Palermo
country: Italy
facility: Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
city: Reggio Emilia
country: Italy
facility: CORE IRCCS Arcispedale Santa Maria Nuova
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria - SC di Oncoematologia
city: Treviso
country: Italy
facility: ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: