Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a retrospective, single-center, non-randomized, non-controlled study. This study aims to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation.
详细描述
High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is the consolidation treatment for advanced lymphoma patients and approved for treating recurrent and refractory lymphoma by prolonging progression-free survival significantly while also improving quality of life. Evidences to date, have validated that changes of T-lymphocyte subsets after autologous stem cell transplantation associated closely with immunologic reconstitution, and have produced amazing effects in prognosis. Whether T-lymphocyte subsets changes could serve as an effective index for prognosis has been a serious question for lymphoma patients treated by autologous stem cell transplantation. In this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma patients before and after autologous stem cell transplantation, and evaluate the significant effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women≥18 years, <65 years;
- •Lymphoma patients treated by autologous stem cell transplantation for the first time;
- •Ccr ≥ 50 ml/min;
- •ALT, AST and TBIL≤2.5-fold upper normal range;
- •Satisfactory heart and lung function;
- •Women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to practice birth control during the study and one year post study;
- •Good compliance and sighed informed consent voluntarily.
- •Patients should be conformed to all inclusion criteria above.
排除标准
- •Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;
- •Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
- •Serious complications;
- •Atopy or allergy to biological product derived from colibacillus;
- •Women who are breastfeeding, pregnant or refused to practice contraception;
- •Severe mental or nervous system diseases;
- •Severe abnormalities of heart, lung and central nervous system symptoms;
- •Patients with sickle cell disease, erythronoclastic anemia or other hematological disease which has an impact on medullary hematopoiesis;
- •Enrolled in other study currently or 30 days before screen;
- •Patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
- •Patients conformed to any of above criteria should be excluded from this study.
研究组 & 干预措施
autologous stem cell transplantation
Lymphoma patients received autologous stem cell transplantation for the first time
干预措施: autologous stem cell transplantation (Biological)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
Progression-free survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis. And it would be measured within 2 years.
Overall survival
时间窗: 2 years
The investigators would measure the overall survival of participants within 2 years. Overall survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis.
次要结局
未报告次要终点
研究者
Jun Zhu
Principal Investigator, Clinical Professor
Peking University