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

Active, not recruiting

• Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

• Registration Number: NCT06760936
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-06-06
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of OS	through study completion, an average of 2 years	patient's survival after both pixantrone and allogenic transplant/CAR-T
causes of discontinuation	through study completion, an average of 2 years	causes of treatment discontinuation
Incidence of adverse events (AE)	through study completion, an average of 2 years	treatment's tolerability
Treatment duration	through study completion, an average of 2 years	Mean treatment duration (time required to achieve a response sufficient to led the patient to allo-HSCT or CAR-T Therapy)
patient's response to the treatment with pixantrone	through study completion, an average of 2 years	Overall response rate (proportion of patients achieving a complete remission, partial remission, stable disease or progressive disease) following treatment with pixantrone
type of adverse events (AE)	through study completion, an average of 2 years	treatment's tolerability
Incidence serious adverse events (SAE)	through study completion, an average of 2 years	treatment's tolerability
PFS (progression free survival)	through study completion, an average of 2 years	patient's survival after both pixantrone and allogenic transplant/CAR-T
type of serious adverse events (SAE)	through study completion, an average of 2 years	treatment's tolerability
disease free survival (DFS)	through study completion, an average of 2 years	patient's survival after both pixantrone and allogenic transplant/CAR-T

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy