Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients (PIXBRIDGE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

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 Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic relapse/refractory DLBCL patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.	Number of patients able to proceed to transplant/CAR-T	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment duration	Mean treatment duration (time required to achieve a response sufficient to led the patient to allo-HSCT or CAR-T Therapy)	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	through study completion, an average of 2 years
type of adverse events (AE)	treatment's tolerability	through study completion, an average of 2 years
Assessment of OS	patient's survival after both pixantrone and allogenic transplant/CAR-T	through study completion, an average of 2 years
causes of discontinuation	causes of treatment discontinuation	through study completion, an average of 2 years
Incidence of adverse events (AE)	treatment's tolerability	through study completion, an average of 2 years
Incidence serious adverse events (SAE)	treatment's tolerability	through study completion, an average of 2 years
type of serious adverse events (SAE)	treatment's tolerability	through study completion, an average of 2 years
PFS (progression free survival)	patient's survival after both pixantrone and allogenic transplant/CAR-T	through study completion, an average of 2 years
disease free survival (DFS)	patient's survival after both pixantrone and allogenic transplant/CAR-T	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CAR-T therapy; pixantrone; allogenic transplant
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: PIXBRIDGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No