NCT04373395Unknown不适用
A Prospective, Single-arm, Multicenter, Exploratory Study to Evaluate the Efficacy and Safety of D-CLAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rate
研究概览
简要总结
A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification.
- •Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells >5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before.
- •Eastern cancer cooperation group (ECOG) ≤
- •Creatinine clearance ≥30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula).
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
- •Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50%.
- •Life expectancy >8 weeks.
- •Voluntarily sign the informed consent and understand and comply with the requirements of the study.
排除标准
- •White blood cell (WBC) > 50 * 109 / L
- •Patients who have received salvage treatment with D-CLAG.
- •Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening.
- •Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes).
- •Pregnant or nursing women.
- •Unable to understand or follow the research protocol or unable to sign the informed consent.
结局指标
主要结局
Complete remission (CR) rate
时间窗: Complete blood count recovery or 1 month after 1 course of D-CLAG regimen
Complete remission rate after 1 course of D-CLAG regimen
次要结局
未报告次要终点
研究者
He Huang
President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University
研究点 (1)
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