Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) none
Not provided
Not provided
Not provided
primary care clinic relapse/refractory DLBCL patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pier Luigi Zinzani, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero - Universitaria di Bologna | Bologna | 40138 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |