NCT05682755招募中1 期
Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study
Sichuan University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年12月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.
Participants will take oral chidamide (Epidaza) until 180 days after 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
- •KPS score > 60 or ECOG score 0-2;
- •The expected survival period > 3 months;
- •Received allo-HSCT and achieved complete remission (CR);
- •Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;
- •No central nervous system involvement or clinical symptoms after transplantation;
- •Those who have no serious functional damage to important organs of the body;
- •Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
- •Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
排除标准
- •Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
- •Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
- •Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
- •Poor graft function (PGF) occurred after allo-HSCT;
- •Combined with other malignant tumors and require treatment;
- •Active GVHD;
- •Have a history of allergy to Chidamide;
- •Pregnant or lactating females;
- •Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
- •Patients with active chronic hepatitis B or active hepatitis C;
- •History of prolonged QT syndrome;
- •Patients considered by other researchers to be unsuitable for this study.
研究组 & 干预措施
Chidamide
Experimental
干预措施: Chidamide (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 2 years
Progression free survival of this group of patients at the end of 2 year
次要结局
- Non-relapse mortality (NRM)(6 months)
- 100 day adverse events (AE)(Day +100)
- Overall survival (OS)(2 years)
- Relapse rate(2 years)
- Cumulative incidence of acute graft versus host disease (aGVHD)(Day +100)
- Cumulative incidence of chronic graft versus host disease (cGVHD)(2 years)
研究者
Jie Ji
Principle Investigator
Sichuan University
研究点 (1)
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