Diffuse Large B Cell Lymphoma (DLBCL)PIXBRIDGENCT06760936
Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy 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
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2022to 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: primary care clinic relapse/refractory DLBCL patients
Who may be able to join
- Patients with relapsed or refractory DLBCL who received pixantrone as last line of therapy prior to allo-HSCT or CAR-T cell therapy or patient's whose therapeutic program is treatment with pixantrone prior to allo-HSCT or CAR-T cell therapy.
- Age ≥ 18 years at enrolment.
- Written informed consent (if applicable).
Who cannot join
- 1) none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
Read the detailed description
The treatment of relapsed/refractory (R/R) diffuse large B-cell lymphomas (DLBCL) presents a challenge to physicians due to the lack of treatment options. Pixantrone is an aza-anthracenedione, which, compared to anthracyclines and anthracenediones, has significantly reduced cardiotoxicity while maintaining good antitumour activity. The applications of pixantrone can be manifold: elderly patients with a second relapse who are unsuitable for transplantation or CAR-T cell therapy, young patients refractory to 2 previous lines of therapy as a bridge to autologous transplantation, bridge to allogeneic transplantation or CAR-T cell therapy, and salvage therapy for relapses after a transplantation or CAR-T approach. In particular, pixantrone could be one of the most suitable agents to link patients to CAR-T cell therapy due to its safety profile and its ability to induce a rapid response in patients sensitive to this agent. However, data in normal clinical practice are still lacking. Hence the need for an Italian multicentre collection to collect as many cases as possible of patients who have received pixantrone as a bridging therapy to allogeneic transplantation or CAR-T cell therapy.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- pixantrone, allogenic transplant, CAR-T therapy
- 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.
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
Number of patients able to proceed to transplant/CAR-T
Measured: through study completion, an average of 2 years
Secondary outcomes (10)
Treatment duration
Mean treatment duration (time required to achieve a response sufficient to led the patient to allo-HSCT or CAR-T Therapy)
Measured: through study completion, an average of 2 years
patient's response to the treatment with pixantrone
Overall response rate (proportion of patients achieving a complete remission, partial remission, stable disease or progressive disease) following treatment with pixantrone
Measured: through study completion, an average of 2 years
type of adverse events (AE)
treatment's tolerability
Measured: through study completion, an average of 2 years
Assessment of OS
patient's survival after both pixantrone and allogenic transplant/CAR-T
Measured: through study completion, an average of 2 years
causes of discontinuation
causes of treatment discontinuation
Measured: through study completion, an average of 2 years
Incidence of adverse events (AE)
treatment's tolerability
Measured: through study completion, an average of 2 years
Incidence serious adverse events (SAE)
treatment's tolerability
Measured: through study completion, an average of 2 years
type of serious adverse events (SAE)
treatment's tolerability
Measured: through study completion, an average of 2 years
PFS (progression free survival)
patient's survival after both pixantrone and allogenic transplant/CAR-T
Measured: through study completion, an average of 2 years
disease free survival (DFS)
patient's survival after both pixantrone and allogenic transplant/CAR-T
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 posted7 Jan 2025
- Study start6 Jun 2022
- 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 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
- Other
- Enrolment
- 15 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
- NCT06760936
- Sponsor's protocol ID
- PIXBRIDGE
- Acronym
- PIXBRIDGE
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 7 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study
- ClinicalTrials.gov ID
- NCT06760936
- Acronym / sponsor ID
- PIXBRIDGE / PIXBRIDGE
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- pixantrone, allogenic transplant, CAR-T therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 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.
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
Detailed description
The treatment of relapsed/refractory (R/R) diffuse large B-cell lymphomas (DLBCL) presents a challenge to physicians due to the lack of treatment options. Pixantrone is an aza-anthracenedione, which, compared to anthracyclines and anthracenediones, has significantly reduced cardiotoxicity while maintaining good antitumour activity. The applications of pixantrone can be manifold: elderly patients with a second relapse who are unsuitable for transplantation or CAR-T cell therapy, young patients refractory to 2 previous lines of therapy as a bridge to autologous transplantation, bridge to allogeneic transplantation or CAR-T cell therapy, and salvage therapy for relapses after a transplantation or CAR-T approach. In particular, pixantrone could be one of the most suitable agents to link patients to CAR-T cell therapy due to its safety profile and its ability to induce a rapid response in patients sensitive to this agent. However, data in normal clinical practice are still lacking. Hence the need for an Italian multicentre collection to collect as many cases as possible of patients who have received pixantrone as a bridging therapy to allogeneic transplantation or CAR-T cell therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic relapse/refractory DLBCL patients
Key inclusion criteria (3 listed)
- Patients with relapsed or refractory DLBCL who received pixantrone as last line of therapy prior to allo-HSCT or CAR-T cell therapy or patient's whose therapeutic program is treatment with pixantrone prior to allo-HSCT or CAR-T cell therapy.
- Age ≥ 18 years at enrolment.
- Written informed consent (if applicable).
Key exclusion criteria (1 listed)
- 1) none
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
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
Time frame: through study completion, an average of 2 years
Number of patients able to proceed to transplant/CAR-T
10 secondary outcomes
Treatment duration
Time frame: through study completion, an average of 2 years
patient's response to the treatment with pixantrone
Time frame: through study completion, an average of 2 years
type of adverse events (AE)
Time frame: through study completion, an average of 2 years
Assessment of OS
Time frame: through study completion, an average of 2 years
causes of discontinuation
Time frame: through study completion, an average of 2 years
Incidence of adverse events (AE)
Time frame: through study completion, an average of 2 years
Incidence serious adverse events (SAE)
Time frame: through study completion, an average of 2 years
type of serious adverse events (SAE)
Time frame: through study completion, an average of 2 years
PFS (progression free survival)
Time frame: through study completion, an average of 2 years
disease free survival (DFS)
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 7 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
1 site 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 1 site 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 7 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 1 site 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?
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy. (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 7 Jan 2025.