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

IRCCS Azienda Ospedaliero-Universitaria di Bologna9 sites in 1 country100 target enrollmentMay 20, 2021

ConditionsDLBCL - Diffuse Large B Cell Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment: 100
Locations: 9
Primary Endpoint: overall response rate (ORR)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 20, 2021

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Age ≥ 18 years at enrolment.
•Written informed consent (if applicable).

Exclusion Criteria

•Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context

Outcomes

Primary Outcomes

overall response rate (ORR)

Time Frame: 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 Outcomes

Overall Survival (OS)(through study completion, an average of 2 years)
Progression Free Survival (PFS)(through study completion, an average of 2 years)
disease free survival (DFS) at 6 months(through study completion, an average of 2 years)
frequency distribution of the causes of death(through study completion, an average of 2 years)
Mean treatment duration(through study completion, an average of 2 years)
Incidence and type of adverse events and severe adverse events(through study completion, an average of 2 years)
Proportion of patients with clinical disease progression(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(through study completion, an average of 2 years)
Best response rate (BRR)(through study completion, an average of 2 years)
frequency distribution of the causes of treatment discontinuation(through study completion, an average of 2 years)