Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients - A Retrospective-prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
研究概览
简要总结
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.
时间窗: through study completion, an average of 2 years
Number of patients able to proceed to transplant/CAR-T
次要结局
- Treatment duration(through study completion, an average of 2 years)
- patient's response to the treatment with pixantrone(through study completion, an average of 2 years)
- type of adverse events (AE)(through study completion, an average of 2 years)
- Incidence serious adverse events (SAE)(through study completion, an average of 2 years)
- Assessment of OS(through study completion, an average of 2 years)
- causes of discontinuation(through study completion, an average of 2 years)
- Incidence of adverse events (AE)(through study completion, an average of 2 years)
- PFS (progression free survival)(through study completion, an average of 2 years)
- type of serious adverse events (SAE)(through study completion, an average of 2 years)
- disease free survival (DFS)(through study completion, an average of 2 years)