Primary Mediastinal B Cell LymphomaPRIMICINCT06781450
Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
An observational study of Primary Mediastinal B Cell Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial summary
Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Mediastinal B Cell Lymphoma
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 23 Apr 2022to Dec 2025
- 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 Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
Who may be able to join
- Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
- Age ≥ 18 years at enrollment
- Signature of written informed consent (where applicable)
Who cannot join
- 1. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera Universitaria- POLICLINICO BARI
Bari, 70124
Pellegrino Musto, MD, +39 0805593471, pellegrino.musto@uniba.it
Francesco Gaudio, MD, francesco.gaudio@policlinico.ba.it
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
Cinzia Pellegrini, MD, +390512143680, cinzia.pellegrini@aosp.bo.it
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Paolo Corradini, MD, +39 0223902950, paolo.corradini@unimi.it
Anna Guidetti, MD, +39 0223902175, anna.guidetti@istitutotumori.mi.it
About this study
Official title: Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory
Read the detailed description
Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate [CR] and partial response rate [PR]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.
Secondary objectives
- To assess efficacy, in terms of:
- Duration of response (DoR)
- Progression-free survival (PFS)
- Overall survival (OS)
- Disease-free survival (DFS)
- Best response rate (achieved at any time during treatment)
- To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.
- Conditions
- Primary Mediastinal B Cell Lymphoma
- Keywords
- pembrolizumab, nivolumab, brentuximab vedotin
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, the sum of complete response [CR] and partial response [PR] rate) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated in a real-life setting from November 2020 through November 2021
Measured: at the end of treatment, through study completion, an average of 2 years
Secondary outcomes (7)
Duration of Response (DoR)
Duration of Response (DoR)
Measured: through study completion, an average of 2 years
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Measured: through study completion, an average of 2 years
Overall Survival (OS)
Overall Survival (OS)
Measured: through study completion, an average of 2 years
Disease Free Survival (DFS)
Disease Free Survival (DFS)
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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin
Measured: through study completion, an average of 2 years
Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin
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 posted17 Jan 2025
- Study start23 Apr 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mediastinal 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
- 50 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
- NCT06781450
- Sponsor's protocol ID
- PRIMICI
- Acronym
- PRIMICI
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 30 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
- ClinicalTrials.gov ID
- NCT06781450
- Acronym / sponsor ID
- PRIMICI / PRIMICI
- Conditions
- Primary Mediastinal B Cell Lymphoma
- Keywords
- pembrolizumab, nivolumab, brentuximab vedotin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 23 Apr 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 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.
Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory
Detailed description
Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate [CR] and partial response rate [PR]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.
Secondary objectives
- To assess efficacy, in terms of:
- Duration of response (DoR)
- Progression-free survival (PFS)
- Overall survival (OS)
- Disease-free survival (DFS)
- Best response rate (achieved at any time during treatment)
- To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.
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 Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
Key inclusion criteria (3 listed)
- Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
- Age ≥ 18 years at enrollment
- Signature of written informed consent (where applicable)
Key exclusion criteria (1 listed)
- 1. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin 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: at the end of treatment, through study completion, an average of 2 years
The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, the sum of complete response [CR] and partial response [PR] rate) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated in a real-life setting from November 2020 through November 2021
7 secondary outcomes
Duration of Response (DoR)
Time frame: through study completion, an average of 2 years
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
Disease 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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 2 years
Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
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 30 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Mediastinal B Cell Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 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: status not confirmed, as of the sponsor's last update on 30 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 3 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 (+390512144042, 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: at the end of treatment, 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 30 Jan 2025.