Diffuse Large B Cell Lymphoma (DLBCL)TALOsNCT06782789
An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 11 sites in Italy.
Trial summary
The study is pilot, observational, retrospective, Italian multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- How many people
- 96 participants
- Where
- 11 sitesItaly
- Study dates
- 1 Mar 2024to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with R/R DLBCL who have received at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022.
Who may be able to join
- Histologically confirmed diagnosis of R/R DLBCL.
- Patientswho received at least one dose of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022.
- Age ≥ 18 years at enrollment.
- Signature of written informed consent (if applicable).
Who cannot join
- 1) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
- Recruiting
AO Sant'Anna e San Sebastiano di Caserta
Caserta, Caserta
Giusy Cetani, MD, +39 0823 232935, giusy.cetani@aorncaserta.it
Giusy Cetani, MD
- Recruiting
A.R.N.A.S. Garibaldi
Catania, Catania
Ugo Consoli, MD, +39 0957595801, ugo.consoli144@gmail.com
Ugo Consoli, MD
- Recruiting
Azienda Ospedaliera Universitaria Arcispedale S. Anna
Ferrara
Giulia Daghia, MD, +39 0532 236978, giulia.daghia@ospfe.it
Maria Rosariaa Sessa, MD, +390532236992, m.sessa@ospfe.it
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Luca Nassi, MD, +39 055 947358, nassil@aou-car.it
Benedetta Sordi, MD, +39 055 7947358, benedetta.sordi@unifi.it
- Recruiting
Irccs Ospedale San Raffaele
Milan, 20132
Andrés José Maria Ferreri, MD, +39 02 2643 4289, ferreri.clinicaltrials@hsr.it
Piera Angelillo, MD, +39 02 2643 3903, angelillo.piera@hsr.it
- Recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, 28100
Riccardo Bruna, MD, +39 03213733127, riccardo.bruna@med.uniupo.it
Giulia Maria Rivolta, MD, +39 0321373312, 20042325@studenti.uniupo.it
- Recruiting
Azienda Ospedaliera Villa Sofia Cervello
Palermo, 90146
Caterina Patti, MD, +39 0916802037, K.patti@villasofia.it
Vittoria Tarantino, MD, +39 0916802773, vittoriatarantino@hotmail.it
- Recruiting
Ospedale Guglielmo da Saliceto di Piacenza
Piacenza, 29100
Patrizia Bernuzzi, MD, +39 0523303719, p.bernuzzi@ausl.pc.it
Annalisa Arcari, MD, +39 0523303719, a.arcari@ausl.pc.it
- Recruiting
IRCCS- Istituto Nazionale Tumori Regina Elena
Roma, 00144
Francesca Palombi, MD, +39 0652665529, francesca.palombi@ifo.it
Daniela Renzi, MD, +39 0652662847, daniela.renzi@ifo.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Francesco D'Alò, MD, +39 3497884529, francesco.dalo@policlinicogemelli.it
Flaminia Bellissario, MD, +39 3391455175, flaminia.bellissario@gmail.com
About this study
The study is pilot, observational, retrospective, Italian multicenter study.
Read the detailed description
The study will involve the collection of patient data from medical records of patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022, in several selected Italian centres. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. In fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- tafasitamab, lenalidomide
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
ORR as the sum of complete response [CR] and partial response [PR] rate. The study aims to retrospectively evaluate the effectiveness of tafasitamab in association with lenalidomide in patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide under the NPP.
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
Duration of Response (DoR)
the secondary aim is to evaluate effectiveness of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017)
Measured: through study completion, an average of 2 years
Toxicity of study drug
Type, incidence, severity of any adverse events (AE) occurred from start of treatment to 30 days after last infusion and their possible relationship with study drugs
Measured: from enrollment untill 30 days from last infusion
Progression Free Survival (PFS)
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Measured: through study completion, an average of 2 years
Overall Survival (OS)
Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.
Measured: through study completion, an average of 2 years
Duration Free Survival (DFS)
Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Mar 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies 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
- 96 participants (estimated)
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
- NCT06782789
- Sponsor's protocol ID
- TALOs
- Acronym
- TALOs
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 20 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program
- ClinicalTrials.gov ID
- NCT06782789
- Acronym / sponsor ID
- TALOs / TALOs
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- tafasitamab, lenalidomide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
The study is pilot, observational, retrospective, Italian multicenter study.
Detailed description
The study will involve the collection of patient data from medical records of patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022, in several selected Italian centres. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. In fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.
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
- Patients with R/R DLBCL who have received at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022.
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of R/R DLBCL.
- Patientswho received at least one dose of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022.
- Age ≥ 18 years at enrollment.
- Signature of written informed consent (if applicable).
Key exclusion criteria (1 listed)
- 1) R/R DLBCL patients who received tafasitamab in association with lenalidomide in 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
ORR as the sum of complete response [CR] and partial response [PR] rate. The study aims to retrospectively evaluate the effectiveness of tafasitamab in association with lenalidomide in patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide under the NPP.
6 secondary outcomes
Duration of Response (DoR)
Time frame: through study completion, an average of 2 years
Toxicity of study drug
Time frame: from enrollment untill 30 days from last infusion
Progression Free Survival (PFS)
Time frame: through study completion, an average of 2 years
Overall Survival (OS)
Time frame: through study completion, an average of 2 years
Duration Free Survival (DFS)
Time frame: through study completion, an average of 2 years
Best response rate (BRR)
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 11 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 4 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: status not confirmed, as of the sponsor's last update on 20 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 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+39 0512144042, pierluigi.zinzani@unibo.it), or a site near the patient. 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 20 Jan 2025.