NCT05807659招募中2 期
Fractionated Busulfan Combined With Chidamide/Fludarabine/Cytarabine (ChiFAB) With Allogeneic Hematopoietic Stem-Cell Transplantation in Non-remission Myeloid Malignancies: a Phase II Study
Sichuan University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年3月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are:
- The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT.
- The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT.
Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2, cytarabine 1g/m2,d-6~-2, chidamide 30mg d-13,-10,-6,-3) before 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;
- •Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%.
- •Those who have no central nervous system involvement or 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;
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;
- •Combined with other malignant tumors and require treatment;
- •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
fractionated busulfan
Experimental
fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2 cytarabine 1g/m2,d-6~-2 chidamide 30mg d-13,-10,-6,-3
干预措施: fractionated busulfan-based conditioning regimen (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years
Overall survival of this group of patients at the end of 2 year
次要结局
- Cumulative incidence of acute graft versus host disease (aGVHD)(Day +100)
- Cumulative incidence of chronic graft versus host disease (cGVHD)(2 years)
- Non-relapse mortality (NRM)(6 months)
- Relapse rate(2 years)
研究者
Jie Ji
Clinical Professor
Sichuan University
研究点 (1)
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