Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical responses in relation with SNP's or gene expression
研究概览
简要总结
Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical & molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate analysis will be done to evaluate factors influencing on response and survival.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: older than 15 years.
- •Male, female.
- •Normal renal & liver functions.
- •Without previous treatment.
- •Candidate to be treated with hyperCVAD Schema (ALL patients).
- •Candidate to receive induction remission with cytarabine (AML patients)
排除标准
- •Patients not candidate to receive methotrexate or cytarabine.
结局指标
主要结局
Clinical responses in relation with SNP's or gene expression
时间窗: clinical response.
To evaluate clinical response
时间窗: December 2012
To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response \& DFS in relation with hENT1 \& dCK expression levels in AML patients.
次要结局
未报告次要终点
研究者
DR. MYRNA CANDELARIA
Clinical researcher.
National Institute of Cancerología