A Clinical Study to Evaluate the Efficacy and Safety of Autologous Hematopoietic Stem Cell Transplantation(ASCT) Bridging Chimeric Antigen Receptor T(CART) Cell Therapy in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
This is a single center, prospective cohort study to to evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation(ASCT) bridging chimeric antigen receptor T (CART) cell therapy in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma.
详细描述
High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation(ASCT) is still the standard salvage treatment for relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL). However, its overall survival (OS) and event-free survival (EFS) of 3 years and above are less than 50%. Chimeric antigen receptor T (CART) cell therapy has shown great efficacy in treating B-NHL in recent years. Preclinical studies have indicated that the infusion of hematopoietic stem cells could promote the amplification and function of adoptive metastatic anti-tumor CD8+T cells, providing a certain theoretical basis for ASCT combined with CART cell therapy. In order to evaluate the efficacy and safety of ASCT bridging CART cell therapy in treating R/R B-NHL, we conduct this single center, prospective cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed B-NHL with extrinsic involvement.
- •Age ≥ 18 years and ≤ 65 years.
- •Measurable disease of at least 15mm(node)/10mm（extranodal）
- •Meet any of the following conditions :
- •After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;
- •Relapsed B-NHL within 12 months after ASCT;
- •After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more.
- •Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2*10^6/kg.
- •Estimated survival time ≥3 months
排除标准
- •Having received allogeneic hematopoietic stem cell transplantation previously;
- •HIV-positive;
- •Active hepatitis B or C infection;
- •Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study.
- •Patients with cardiac insufficiency:ejection fraction (EF) < 30%, NYHA standard, grade II or above
- •Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) > 2.5 times the up, Serum Creatinine (SCR) > 2.5mg/ dL (221μmol/L)
- •Female patients who are pregnant, preparing to become pregnant or lactating.
- •The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
结局指标
主要结局
Overall Survival(OS)
时间窗: up to 12 months
The interval from the time of ASCT to death from any cause or to the last follow-up moment.
Progression-free Survival(PFS)
时间窗: up to 12 months
The last follow-up of a surviving patient after ASCT to the date of relapse, disease progression, death, dependent upon which occurred first over a follow-up period of 18 months.
次要结局
- Overall Response Rate(ORR)(up to 12 months)
- Duration of Response(DOR)(up to 12 months)
- Adverse Events(AE)(Measured from start of treatment until 28 days after last treatment.)
- Cumulative Recurrence Rate(up to 12 months)