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

Active, not recruiting

• Conditions: DLBCL - Diffuse Large B Cell Lymphoma

• Registration Number: NCT06734078
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2021-05-20
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-16
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Mean treatment duration	through study completion, an average of 2 years	Mean treatment duration
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)
frequency distribution of the causes of treatment discontinuation	through study completion, an average of 2 years	frequency distribution of the causes of treatment discontinuation

Trial Locations

Locations (9)

Casa Sollievo della Sofferenza - Reparto di Oncoematologia; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Azienda Ospedaliera Universitaria- Policlinico di Bari; 🇮🇹 Bari, Italy

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy

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