Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06760936

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

Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Treatment duration

    Time frame: 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)

  2. patient's response to the treatment with pixantrone

    Time frame: 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

  3. type of adverse events (AE)

    Time frame: through study completion, an average of 2 years

    treatment's tolerability

  4. Assessment of OS

    Time frame: through study completion, an average of 2 years

    patient's survival after both pixantrone and allogenic transplant/CAR-T

  5. causes of discontinuation

    Time frame: through study completion, an average of 2 years

    causes of treatment discontinuation

  6. Incidence of adverse events (AE)

    Time frame: through study completion, an average of 2 years

    treatment's tolerability

  7. Incidence serious adverse events (SAE)

    Time frame: through study completion, an average of 2 years

    treatment's tolerability

  8. type of serious adverse events (SAE)

    Time frame: through study completion, an average of 2 years

    treatment's tolerability

  9. PFS (progression free survival)

    Time frame: through study completion, an average of 2 years

    patient's survival after both pixantrone and allogenic transplant/CAR-T

  10. disease free survival (DFS)

    Time frame: through study completion, an average of 2 years

    patient's survival after both pixantrone and allogenic transplant/CAR-T

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study

Acronym: PIXBRIDGE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.