Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
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
15
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
Number of patients able to proceed to transplant/CAR-T
Time frame: through study completion, an average of 2 years
Treatment duration
Mean treatment duration (time required to achieve a response sufficient to led the patient to allo-HSCT or CAR-T Therapy)
Time frame: 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
Time frame: through study completion, an average of 2 years
type of adverse events (AE)
treatment's tolerability
Time frame: through study completion, an average of 2 years
Assessment of OS
patient's survival after both pixantrone and allogenic transplant/CAR-T
Time frame: through study completion, an average of 2 years
causes of discontinuation
causes of treatment discontinuation
Time frame: through study completion, an average of 2 years
Incidence of adverse events (AE)
treatment's tolerability
Time frame: through study completion, an average of 2 years
Incidence serious adverse events (SAE)
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treatment's tolerability
Time frame: through study completion, an average of 2 years
type of serious adverse events (SAE)
treatment's tolerability
Time frame: through study completion, an average of 2 years
PFS (progression free survival)
patient's survival after both pixantrone and allogenic transplant/CAR-T
Time frame: through study completion, an average of 2 years
disease free survival (DFS)
patient's survival after both pixantrone and allogenic transplant/CAR-T
Time frame: through study completion, an average of 2 years