Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a prospective observational cohort study of haploidentical transplantation with post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia (ALL).
详细描述
Hematopoietic stem cell transplantation (HSCT) is the most effective treatment for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), with the lowest rates of relapse.
Fertility rate in Brazil is falling, and only 25% of people born today will have a matched sibling donor. On the other hand, currently donor non-related to about 50% of patients enrolled in Brazilian Receptor Registry (REREME). Consequently, at least 35% of patients won't have a matched donor.
The haploidentical transplantation is defined as a partially matched hematopoietic cell transplantation, using a partially matched family donor (parent, sibling or child). Haploidentical transplantation activity is growing worldwide, with results comparable matched unrelated donors.
The objective of this study is to test the feasibility of haploidentical transplantation with post transplant cyclophosphamide for acute leukemias in a Brazil.
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
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute lymphoblastic leukemia or acute myeloid leukemia
排除标准
- •Severe comorbidities
- •Second transplant
结局指标
主要结局
Overall Survival
时间窗: 1 year
1-year overall survival. Survival curves will be estimated by Kaplan-Meier methodology.
次要结局
- Cumulative incidence of leukemia relapse(5 years)
- Transplant Related Mortality(6 months)
- Cumulative Incidence of acute Graft Versus Host Disease(5 years)
- Cumulative Incidence of chronic Graft Versus Host Disease(5 years)
- Cumulative Incidence of Infectious Complications(1 year)
研究者
Leonardo Javier Arcuri
Physician
Instituto Nacional de Cancer, Brazil