A Retrospective and Prospective Multicenter Observational Study for the Evaluation of Incidence of Systemic Mastocytosis With Associated t(8;21) Acute Myeloid Leukemia in t(8;21) Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia
研究概览
简要总结
The observational study aimed at evaluating the incidence of systemic mastocytosis associated with t(8;21) AML in patients with de novo t(8;21) AML and their responses to first induction, and the prognosis from standard therapy.
详细描述
This is a multicenter, retrospective and prospective, observational study that aims to collect clinical information on patients with systemic mastocytosis associated with t(8;21) AML from September 2022 to August 2023. No intervention is expected.
The purpose of this study is to identify and characterize the patients with systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and OSM (Oligo-mastocytic SM) with associated t(8;21) AML.
In order to estimate the incidence of systemic mastocytosis associated with t(8;21) AML, a survey will be sent every month to all participating sites to collect the number of all diagnoses of systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and OSM with associated t(8;21) AML. All patients will be followed until August 2025 in order to have at least 2 years of observation.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, Age (years) >= 5;
- •Newly diagnosed as t(8;21) AML patients according to World Health Organization (WHO) classification;
- •Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
排除标准
- •The t(8;21) AML patients with SM have been diagnosed already;
- •Patients with drug abuse or long-term alcoholism that affected the evaluation of trial results;
- •Patients were deemed unsuitable for enrolment by the investigator.
结局指标
主要结局
Incidence of Systemic Mastocytosis associated with t(8;21) Acute Myeloid Leukemia
时间窗: at 1 year
Evaluation of the incidence of systemic mastocytosis associated with t(8;21) AML in patients with de novo t(8;21) AML. The incidence of systemic mastocytosis associated with t(8;21) AML will be evaluated by means of the number of diagnosis of systemic mastocytosis associated with t(8;21) AML on the number of all diagnoses of de novo t(8;21) AML between September 2022 and August 2023.
次要结局
- Hematological characteristics of all the t(8;21) Acute Myeloid Leukemia(at 1 year)
- Responses to the first induction therapy of all the t(8;21) Acute Myeloid Leukemia(at 1 year)
- Incidence of transplantation of all the t(8;21) Acute Myeloid Leukemia(at 1 year)
- Survival Distribution of all the t(8;21) Acute Myeloid Leukemia(at 2 years)
研究者
Chen Suning
Director, Clinical Professor
The First Affiliated Hospital of Soochow University