NCT03083054Unknown1 期
Cellular Immunotherapy as a Treatment Option for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Disease free survival
研究概览
简要总结
The main objective of this work is to conduct a clinical study for the development and application of a vaccine with autologous dendritic cells submitted to electroporation with Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the disease or its relapse and increase overall and event-free survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between the ages of 18 and 70
- •High-risk myelodysplasia (AREB 1 or AREB 2 subtypes) and Acute Myeloid Leukemia
- •Minimum interval of 30 days between the last cycle of chemotherapy (when it occurs) and start of immunotherapy
- •Performance status between 0 and 3 on the WHO (World Health Organization)-ECOG (Eastern Cooperative Oncology Group) scale
- •Calculated creatinine clearance> 30 ml / min using the Cockcroft-Gault formula
- •Total bilirubin less than or equal to twice the lower limit of the normal range in the institution and aspartate aminotransferase (AST) less than or equal to twice the upper limit of normal
- •Absence of blasts in peripheral blood
- •Leukocyte count greater than 3000 cells / mm3, hemoglobin greater than 9.0 g / dl and platelets greater than 70,000 platelets / mm3, if possible. (If the patient does not meet these criteria for apheresis, the possibility of transfusion of blood components after leukapheresis will be proposed and the patient should sign a specific term of science on the possibility of transfusion)
- •Normal cardiac evaluation
- •Negative serologies for hepatitis B and C viruses and HIV
- •Written informed consent form signed before entering the study
排除标准
- •Does not meet any of the requirements of the inclusion criteria
- •Low risk myelodysplasia by IPSS (International Prognostic Scoring System) or WPSS (WHO adapted Prognostic Scoring System) scores
- •Individuals with a history of any previous neoplasia, except those with prolonged clinical remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ
- •Pregnant or lactating women
- •Previous immunotherapy or biological therapy
结局指标
主要结局
Disease free survival
时间窗: 12 months
次要结局
未报告次要终点
研究者
Bruno Deltreggia Benites
Principal Investigator
University of Campinas, Brazil
研究点 (2)
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