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Clinical Trials in Italy / NCT06734078
Active, not recruiting Observational

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

NCT06734078 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2021-05-20
Last updated
2025-01-29

Condition(s) studied

DLBCL - Diffuse Large B Cell Lymphoma

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • overall response rate (ORR) — 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.

Trial sites (9)

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

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Other trials for the same condition

Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734078 on ClinicalTrials.gov ↗ ← All trials in Italy