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NCT Number: NCT06734078

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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 ...

  2. 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

  3. 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.

  4. frequency distribution of the causes of death

    Time frame: through study completion, an average of 2 years

    frequency

  5. Mean treatment duration

    Time frame: through study completion, an average of 2 years

    Mean treatment duration

  6. Incidence and type of adverse events and severe adverse events

    Time frame: through study completion, an average of 2 years

    Incidence

  7. Proportion of patients with clinical disease progression

    Time frame: through study completion, an average of 2 years

    Proportion

  8. 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

  9. Best response rate (BRR)

    Time frame: through study completion, an average of 2 years

    Best response rate (BRR)

  10. 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: POSS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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