Observation of the Effect of Chemotherapy Combined With Tyrosinase Inhibitor on the Reactivation of CMV and EBV in Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CMV and EBV reactivation rate
研究概览
简要总结
Philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (ALL) preferred chemotherapy combined with tyrosine kinase inhibitors (TKIS) therapy. Recently we found that there were cytomegalovirus reactivation and even cytomegalovirus infection in three ALL patients treated with chemotherapy combined with TKIs. However, the cytomegalovirus risk after dasatinib use in patients with philadelphia-chromosome-positive ALL is still unknown. It is reported that dasatinib can be observed in the treatment of philadelphia-chromosome-positive leukemia patients with significant increase in large granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's prognosis is relatively good. Dasatinib can inhibit SRC and TEC kinase, and induce immune function inhibition,and in vitro experiments have confirmed that it inhibits the immune function of T cells and NK cells. In this study, we examined the potential association between cytomegalovirus AND EBV reactivation the treatment of chemotherapy combined with TKIs, and the numbers of large granular cells and NK cell activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with acute lymphoblastic leukemia who had not previously received chemotherapy (except for hormone preconditioning) or started with chemotherapy but not more than 3 days, and CMV and EBV quantitative negative;
- •Age Limits:>or= 14 years old.
排除标准
- •Patients who had previously received chemotherapy and hematopoietic stem cell transplantation;
- •Patients with CMV and EBV infection before treatment and not to turn yin;
- •The researchers considered unsuitable patients.
研究组 & 干预措施
Chmotherapy combined with TKIs
Patients with ALL were treated by chmotherapy and TKIs(PDT-NFH-2016)
干预措施: TKIs (Drug)
结局指标
主要结局
CMV and EBV reactivation rate
时间窗: 2 years
Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients
次要结局
- The number of large granulosa cells and T、B、NK cell activity(2 years)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University