Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment.
Adult patients >18 years of age who can be included:
Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant AML.
Treatment: Combined therapy with:
Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.
详细描述
Patients to be included:
- Elderly patients (>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
- Adult patients of any age (>18 years of age) with relapsed or resistant AML who cannot receive conventional therapy.
Treatment:
Valproic acid to be started on day 1 as continuous therapy until disease progression.
ATRA administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month.
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
- •Recently diagnosed AML in patients unfit for intensive chemotherapy
- •Patients with relapsed or refractory AML
排除标准
- •No informed consent
- •Intolerance to study drugs
- •Serious liver disease
研究组 & 干预措施
ATRA+valproc acid+low-dose cytarabine
干预措施: Cytarabine, all-trans retinoic acid, valproic acid (Drug)
结局指标
主要结局
Survival
时间窗: 3 years
次要结局
- Disease complications(3 years)
- Disease stabilization(3 years)
- Side effects of therapy(3 years)
研究者
Øystein Bruserud
Professor
University of Bergen