Multicenter, Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions (DLI) Versus Best Available Treatment (BAT) in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 主要终点
- Response to treatment
研究概览
简要总结
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT.
详细描述
The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT
- •Age ≥18 years
- •Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI
- •Written informed consent
- •Ability to understand the nature of the study and the study related procedures and to comply with them
排除标准
- •Age < 18 years
- •Lack of informed consent
- •Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group
结局指标
主要结局
Response to treatment
时间窗: 10 years
The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.
次要结局
- Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants.(10 years)
- Number of participants with acute graft-versus-host disease (GvHD).(10 years)
- Overall survival (OS) of the participants(10 years)
研究者
Robert Zeiser
Head of Tumor Imunnology and Immun regulation
University of Freiburg