A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin in the Treatment of Patients With Transplantation Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Investigator-assessed best overall response (BOR)
研究概览
简要总结
To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.
详细描述
This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Hospitalized patients Patients who enrolled in the Pola CUP program and met the following criteria:
- •Histologically confirmed DLBCL, patients have exhausted all therapeutic options for DLBCL and have been treated with at least two prior lines of therapy including R-CHOP (or similar regimen for 1L DLBCL)
- •Not considered to be eligible for Bone Marrow Transplantation (BMT) (both allogenic or autologous)
- •Have documented recent progression following or during last treatment, or became intolerant to the last treatment
- •Does not have ≥ Grade 2 peripheral neuropathy(PN) prior to receiving Pola
- •Patients treated with Pola-BR or Pola-R regimens
排除标准
- •Patients participating in other clinical studies of Pola.
研究组 & 干预措施
Pola BR/R
Patients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens.
干预措施: Polatuzumab Vedotin-Piiq (Drug)
结局指标
主要结局
Investigator-assessed best overall response (BOR)
时间窗: From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)
Best overall response (BOR) assessed by the investigator, is based on either PET-CT or CT, and defined as the percentage of patients with CR or PR.
次要结局
- Duration of response (DOR)(From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months)
- Progression free survival (PFS)(From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months)
- Objective response rate (ORR)(At end of the treatment(up to six cycles, each cycle is 21 days))
- Complete response (CR)(At end of the treatment(up to six cycles, each cycle is 21 days))
研究者
Jianqiu Wu
Director of lymphoma department
Jiangsu Cancer Institute & Hospital