NCT06379360招募中2 期
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2020年11月1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
- 77
- 试验地点
- 1
- 主要终点
- Relapse free survival (RFS)
研究概览
简要总结
HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.
详细描述
Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥16 years;
- •Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2022;
- •Patients achieved remission after induction therapy and finished at least 3 cycles of high-dose Aar-C based consolidation therapy, remaining in minimal residual disease (MRD) negative remission status (For NPM1-mutated and core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as <2%, CEBPA-mutated AML, MRD negative is defined as <0.1%).
- •Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Expected survival time ≥ 3 months;
- •No serious heart, lung, liver or kidney disease;
- •Have the ability to understand and be willing to sign the informed consent form for this trial.
排除标准
- •Patients experienced hematologic relapse before recruitment.
- •Patients who are allergic to the study drug or drugs with similar chemical structures.
- •Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- •Active infection.
- •Active bleeding.
- •Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
- •Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
- •Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (AST) > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value).
- •Patients with a history of clinically significant Corrected QT Interval (QTc) prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
- •Surgery on the main organs within the past six weeks.
- •Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation).
- •Patients not suitable for the study according to the investigator's assessment.
研究组 & 干预措施
HMA maintenance therapy
Experimental
All enrolled patients received maintenance therapy consisting of azacitidine or decitabine.
干预措施: Hypomethylating agent, Azacitidine or Decitabine (Drug)
结局指标
主要结局
Relapse free survival (RFS)
时间窗: 5 year
It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause; subjects not known to have any of these events are censored on the date they were last examined.
次要结局
- Cumulative incidence of relapse (CIR)(5 year)
- Overall survival (OS)(5 year)
研究者
Sheng-Li Xue, MD
Principal Investigator
The First Affiliated Hospital of Soochow University
研究点 (1)
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