Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Complete remission rate, duration of complete remission, toxicities
研究概览
简要总结
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
详细描述
-
A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
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G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
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For the patients who achieve a complete remission, consolidation therapy will be given as follows:
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Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
-
In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
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In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure to achieve CR after initial induction chemotherapy
- •Any relapse, regardless of the frequency and time of relapse from first CR
- •Relapse after hematopoietic cell transplantation, allogeneic or autologous.
- •Multiple relapses, extramedullary relapse(s)
排除标准
- •Inadequate hepatic,renal,cardiac function
- •Psychiatric disorder or mental deficiency
- •CNS involvement of leukemic blasts
结局指标
主要结局
Complete remission rate, duration of complete remission, toxicities
次要结局
- progression-free survival, overall survival