NCT07449286尚未招募2 期
A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of relapse
研究概览
简要总结
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients
- •Male or female, aged 12-65 years
- •Karnofsky score >60, estimated survival time >3 months
- •No history of severe graft-versus-host disease (GVHD), uncontrolled
- •GVHD, or severe systemic organ dysfunction:
- •Absolute neutrophil count (ANC) greater than 0.5×109/L
- •Creatinine < 1.5mg/dL
- •Cardiac ejection index >55%
- •Signed informed consent.
排除标准
- •severe cardiac, renal, or liver dysfunction
- •combined with other malignant tumors requiring treatment
- •inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- •patients who are unable to complete the necessary treatment plan and follow-up observation
- •patients with severe acute anaphylaxis
- •clinically uncontrolled severe life-threatening infections
- •patients enrolled in other clinical trials
- •other reasons considered by the investigator to be inappropriate for clinical trial participants.
研究组 & 干预措施
IFN-α application in TP53+ myeloid malignancy
Experimental
干预措施: IFN-α (Drug)
结局指标
主要结局
The incidence of relapse
时间窗: 1 year post HSCT
Disease relapse was defined as blasts ≥ 5% post transplantation
次要结局
- The incidence of non-relapse mortality(1 year post HSCT)
- The incidence of positive minimal residual disease post allo-HSCT(1 year post HSCT)
- The incidence of acute and chronic graft versus host disease (GvHD)(aGvHD within 100 days and cCvHD within 1 year)
- The probability of progression free survival(1 year post HSCT)
- The probability of overall survival (OS)(1 year post HSCT)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital
研究点 (1)
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