DLBCL - Diffuse Large B Cell LymphomaPOSSNCT06734078
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 of DLBCL - Diffuse Large B Cell Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 9 sites in Italy.
Trial summary
Study designobservational, non-interventional, retrospective, multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- How many people
- 100 participants
- Where
- 9 sitesItaly
- Study dates
- 20 May 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Azienda Ospedaliera Universitaria- Policlinico di Bari
Bari, 70124
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Ospedale Oncologico Armando Businco
Cagliari, 09121
Ospedale Maggiore della Carità
Novara, 28100
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo, 90146
CORE IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Casa Sollievo della Sofferenza - Reparto di Oncoematologia
San Giovanni Rotondo, Foggia, 71013
Azienda Ospedaliera Santa Maria - SC di Oncoematologia
Terni, 05100
ULSS2 - Ospedale Civile Ca' Foncello - UO Ematologia
Treviso, 31100
About this study
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.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- bendamustine, rituximab, polatuzumab vedotin
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (10)
Overall Survival (OS)
is the length of time from either the date of diagnosis or the start of treatment ...
Measured: through study completion, an average of 2 years
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
Measured: through study completion, an average of 2 years
disease free survival (DFS) at 6 months
the time from random assignment to cancer recurrence or death from any cause.
Measured: through study completion, an average of 2 years
frequency distribution of the causes of death
frequency
Measured: through study completion, an average of 2 years
Mean treatment duration
Mean treatment duration
Measured: through study completion, an average of 2 years
Incidence and type of adverse events and severe adverse events
Incidence
Measured: through study completion, an average of 2 years
Proportion of patients with clinical disease progression
Proportion
Measured: 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
Proportion of patients with clinical disease progression
Measured: through study completion, an average of 2 years
Best response rate (BRR)
Best response rate (BRR)
Measured: through study completion, an average of 2 years
frequency distribution of the causes of treatment discontinuation
frequency distribution of the causes of treatment discontinuation
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734078
- Sponsor's protocol ID
- POSS
- Acronym
- POSS
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06734078
- Acronym / sponsor ID
- POSS / POSS
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- bendamustine, rituximab, polatuzumab vedotin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study designobservational, non-interventional, retrospective, multicenter study.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 2 years
Progression Free Survival (PFS)
Time frame: 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
frequency distribution of the causes of death
Time frame: through study completion, an average of 2 years
Mean treatment duration
Time frame: 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
Proportion of patients with clinical disease progression
Time frame: 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
Best response rate (BRR)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for DLBCL - Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.