KCT0003694尚未招募未知
Synergistic APProach of continuous Fludarabine, Cytarabine and etoposIde for RElapsed or refractory acute myeloid leukemia
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •R/R AML to receive salvage therapy as the secondary chemotherapy
- •- Those who did not achieve CR after the primary induction chemotherapy for the newly diagnosed, therapy naïve AML (if re-induction therapy is performed according to the preliminary plan for primary induction chemotherapy, it is considered that the first-line therapy is performed only.)
- •- Those who achieved the first CR after the primary induction chemotherapy for a newly diagnosed, therapy naïve AML and relapsed for the first time (if consolidation therapy is performed without a relapse, it is considered that the first-line therapy is performed only.)
- •- Cases in which HCT is performed after first CR and relapsed, yet other chemotherapies were not performed
- •- Aged 18 years and over
- •- Obtaining the informed consent with signature and dates
- •- Healthy liver and kidneys (AST, ALT, bilirubin, and creatinine levels below the normal upper limit by 2.5 times). A rise in the AST or ALT levels caused by the infiltration of leukemic cells into the liver is allowed.
- •- Healthy heart (heart scanning or echocardiography shows over 45% of left ventricular ejection fraction.)
排除标准
- •- Acute leukemia or leukemia accompanied by t(15;17) or PML/RAR gene arrangement
- •- Invasion of leukemia into the central nervous system
- •- Extramedullary granulocytic sarcoma without invasion into the bone marrow
- •- Patients who’ve received treatment for leukemia more than twice; excluding those who were administered with hydroxyurea to reduce the number of leukemic cells prior to remission induction therapy and received consolidation therapy/HCT without a relapse after first CR
- •- Severe active infections
- •- Uncontrollable bleeding
- •- Patients with severe bone marrow depression
- •- Patients who were hypersensitive to etoposide and etoposide components
- •- Patients with renal failure showing serum creatinine clearance <30ml/min
- •- Breastfeeding and pregnant women and fertile women who refuse contraception
- •- Those who are free from diseases in less than five years after radical treatment for other cancers (excluding nonmelanoma skin cancer, intraepithelial carcinoma, and cervical intraepithelial neoplasia radically removed)
- •- Those who experienced severe cardiovascular disorders including cardiac infarction in the last six months
- •- Those with major accompanying diseases or organ failure
- •- Those who have ever been administered with fludarabine to treat AML (not applicable to those administered with it for the pre-treatment of HCT)
- •- Patients difficult to comply with treatment due to Psychiatric or cognitive problems
- •- Patients hypersensitive to granulocyte colony stimulating factor drugs
研究者
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