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

NCT06734078 | Active Not Recruiting

• 1 other identifier: POSS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

Study designobservational, non-interventional, retrospective, multicenter study.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Keywords

bendamustine; rituximab; polatuzumab vedotin

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 years

Secondary Outcomes (10)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (9)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Casa Sollievo della Sofferenza - Reparto di Oncoematologia

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Azienda Ospedaliera Universitaria- Policlinico di Bari

Bari, 70124, Italy

Location

Ospedale Oncologico Armando Businco

Cagliari, 09121, Italy

Location

Ospedale Maggiore della Carità

Novara, 28100, Italy

Location

Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

Palermo, 90146, Italy

Location

CORE IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Azienda Ospedaliera Santa Maria - SC di Oncoematologia

Terni, 05100, Italy

Location

ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia

Treviso, 31100, Italy

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 16, 2024
• Study Start: May 20, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9)