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

NCT ID: NCT06734078

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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DLBCL - Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pier Luigi Zinzani, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

Site Status

Casa Sollievo della Sofferenza - Reparto di Oncoematologia

San Giovanni Rotondo, Foggia, Italy

Site Status

Azienda Ospedaliera Universitaria- Policlinico di Bari

Bari, , Italy

Site Status

Ospedale Oncologico Armando Businco

Cagliari, , Italy

Site Status

Ospedale Maggiore della Carità

Novara, , Italy

Site Status

Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

Palermo, , Italy

Site Status

CORE IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Azienda Ospedaliera Santa Maria - SC di Oncoematologia

Terni, , Italy

Site Status

ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia

Treviso, , Italy

Site Status

Countries

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Italy

Other Identifiers

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POSS

Identifier Type: -

Identifier Source: org_study_id

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