IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138, Italy
NCT Number: NCT06760936
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Bologna, 40138, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 2 years
Number of patients able to proceed to transplant/CAR-T
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)
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
Time frame: through study completion, an average of 2 years
treatment's tolerability
Time frame: through study completion, an average of 2 years
patient's survival after both pixantrone and allogenic transplant/CAR-T
Time frame: through study completion, an average of 2 years
causes of treatment discontinuation
Time frame: through study completion, an average of 2 years
treatment's tolerability
Time frame: through study completion, an average of 2 years
treatment's tolerability
Time frame: through study completion, an average of 2 years
treatment's tolerability
Time frame: through study completion, an average of 2 years
patient's survival after both pixantrone and allogenic transplant/CAR-T
Time frame: through study completion, an average of 2 years
patient's survival after both pixantrone and allogenic transplant/CAR-T
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study
Acronym: PIXBRIDGE
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.
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