Phase 1 Study of Deferasirox in Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- complete Remission
研究概览
简要总结
The purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).
详细描述
Many studies have demonstrated that Iron is essential for the metabolism, cell cycle regulation and metastasis in different cancer cell lines. It is also believed that Iron concentration will increase in cancer cells by enhancing expression of TFR-1 receptors and in case of receptor saturation, non-receptor-mediated pinocytosis would be a significant pathway for more iron intake. Iron deficiency may lead to increase P 53 which consequently will stop cell mitosis in G1-S state. It also increases expression of N-myc down-regulated gene 1 which can suppress metastasis in cancer. It has been suggested that Iron chelators may decrease leukemic tumor growth in animal models of acute myeloid leukemia (AML). Some other case studies demonstrated the role of Iron chelators in relapse and/or refractory AML. Finally a phase 1 clinical study is undertaken for evaluate the role of Tiapine and cytarabine for adult AML and high-risk myelodysplastic syndrome. So in this study the investigators try to evaluate the role of iron chelating agent (deferasirox) for patients with acute lymphatic leukemia (ALL) and AML patients who cannot be treated with standard chemotherapy regimes .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons:
- •existence of another illness, such as heart failure (EF> 40)
- •Ferritin < 500 μg / l
- •Not existence of other co morbidity
排除标准
- •Control group become iron overloaded (Ferritin > 500 μg /l)
- •Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
- •Not willing to continue treatment.
研究组 & 干预措施
deferasirox + cytarabine
deferasirox + cytarabine group will receive oral deferasirox at 20 mg/kg per day and cytarabine at20 mg/m^2 , SC , two times a day for 10 days every 30 days for 1 cycle.
干预措施: Cytarabine (Drug)
deferasirox + cytarabine
deferasirox + cytarabine group will receive oral deferasirox at 20 mg/kg per day and cytarabine at20 mg/m^2 , SC , two times a day for 10 days every 30 days for 1 cycle.
干预措施: Deferasirox (Drug)
cytarabine
cytarabine group will receive just cytarabine at 20 mg/m^2 , SC , two times a day for 10 days every 30 days for 1 cycle.
干预措施: Cytarabine (Drug)
结局指标
主要结局
complete Remission
时间窗: first month
次要结局
- Partial Remission(up to four weeks)
研究者
Golnaz Vaseghi
Dr
Isfahan University of Medical Sciences
