Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.
详细描述
Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR
- •Age >= 18 years
- •Life expectancy of at least three months (without consideration of AML and complications)
- •Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications)
- •Written informed consent
排除标准
- •Prior therapy of AML with cladribine
- •Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection)
- •Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- •Severe renal insufficiency with a clearance of < 30 ml/min (if not due to AML)
- •Severe hepatic insufficiency with bilirubin > 3 mg/dl or AST > 200 U/l (if not due to AML)
- •Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study)
- •HIV infection
- •Intolerance to study drugs
- •Pregnant or breast-feeding women
- •Any other malignant disease which will probably affect the course of AML
结局指标
主要结局
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
时间窗: continuous
Rate of complete remission
次要结局
- Remission duration
- Overall survival
- Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival
- Course of CD3/CD4+ subpopulation after therapy