Clinical trial NCT06760936: Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients
Official title: Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Keywords: pixantrone
allogenic transplant
CAR-T therapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic relapse/refractory DLBCL patients

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age ≥ 18 years at enrolment.
3. Written informed consent (if applicable).

Exclusion Criteria:

1) none

Primary outcomes:
measure: Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Treatment duration
timeFrame: through study completion, an average of 2 years
measure: patient's response to the treatment with pixantrone
timeFrame: through study completion, an average of 2 years
measure: type of adverse events (AE)
timeFrame: through study completion, an average of 2 years
measure: Assessment of OS
timeFrame: through study completion, an average of 2 years
measure: causes of discontinuation
timeFrame: through study completion, an average of 2 years
measure: Incidence of adverse events (AE)
timeFrame: through study completion, an average of 2 years
measure: Incidence serious adverse events (SAE)
timeFrame: through study completion, an average of 2 years
measure: type of serious adverse events (SAE)
timeFrame: through study completion, an average of 2 years
measure: PFS (progression free survival)
timeFrame: through study completion, an average of 2 years
measure: disease free survival (DFS)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: