Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Keywords
pixantrone, allogenic transplant, CAR-T therapy
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Incidence serious adverse events (SAE) | through study completion, an average of 2 years | treatment's tolerability |
| type of 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 |
| disease free survival (DFS) | through study completion, an average of 2 years | patient's survival after both pixantrone and allogenic transplant/CAR-T |
| Incidence of adverse events (AE) | through study completion, an average of 2 years | treatment's tolerability |
Countries
Italy
Outcome results
None listed