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 (POSS)

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study designobservational, non-interventional, retrospective, multicenter study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliera Universitaria- Policlinico di Bari
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero - Universitaria di Bologna
      • Cagliari, Italy, 09121
        • Ospedale Oncologico Armando Businco
      • Novara, Italy, 28100
        • Ospedale Maggiore della Carità
      • Palermo, Italy, 90146
        • Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
      • Reggio Emilia, Italy, 42123
        • CORE IRCCS Arcispedale Santa Maria Nuova
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria - SC di Oncoematologia
      • Treviso, Italy, 31100
        • ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Casa Sollievo della Sofferenza - Reparto di Oncoematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: through study completion, an average of 2 years
is the length of time from either the date of diagnosis or the start of treatment ...
through study completion, an average of 2 years
Progression Free Survival (PFS)
Time Frame: 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
through study completion, an average of 2 years
disease free survival (DFS) at 6 months
Time Frame: through study completion, an average of 2 years
the time from random assignment to cancer recurrence or death from any cause.
through study completion, an average of 2 years
frequency distribution of the causes of death
Time Frame: through study completion, an average of 2 years
frequency
through study completion, an average of 2 years
Mean treatment duration
Time Frame: 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
Time Frame: through study completion, an average of 2 years
Incidence
through study completion, an average of 2 years
Proportion of patients with clinical disease progression
Time Frame: through study completion, an average of 2 years
Proportion
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
Time Frame: through study completion, an average of 2 years
Proportion of patients with clinical disease progression
through study completion, an average of 2 years
Best response rate (BRR)
Time Frame: 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
Time Frame: through study completion, an average of 2 years
frequency distribution of the causes of treatment discontinuation
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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