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Active, not recruitingNCT06734078POSSUpdated Jan 29, 2025

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

An observational study in DLBCL - Diffuse Large B Cell Lymphoma, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 9 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • DLBCL - Diffuse Large B Cell Lymphoma

Keywords

  • bendamustine
  • rituximab
  • polatuzumab vedotin
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 100 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
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What researchers measure

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.

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

Secondary outcomes

  1. Overall Survival (OS)

    is the length of time from either the date of diagnosis or the start of treatment ...

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

  2. Progression Free Survival (PFS)

    the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease

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

  3. disease free survival (DFS) at 6 months

    the time from random assignment to cancer recurrence or death from any cause.

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

  4. frequency distribution of the causes of death

    frequency

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

  5. Mean treatment duration

    Mean treatment duration

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

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

    Incidence

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

  7. Proportion of patients with clinical disease progression

    Proportion

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

  8. Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions

    Proportion of patients with clinical disease progression

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

  9. Best response rate (BRR)

    Best response rate (BRR)

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

  10. frequency distribution of the causes of treatment discontinuation

    frequency distribution of the causes of treatment discontinuation

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

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06734078
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
May 20, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 29, 2025

Study contacts

Pier Luigi Zinzani, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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