Clinical Trial on DLBCL - Diffuse Large B Cell Lymphoma - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

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

Observational

Enrollment (Actual)

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

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:

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

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

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

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

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)

May 20, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)