NCT01055483已完成1 期
A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicity (DLT)
研究概览
简要总结
The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.
- •First relapsed AML
- •Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
- •Age more than 18 years
- •ECOG performance status < 2
排除标准
- •Prior treatment with deacetylase inhibitor
- •Concurrent therapy with any other investigational agent
- •Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
- •Clinical symptoms suggesting CNS leukemia
- •LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LBH589
Experimental
干预措施: panobinostat/LBH589B (Drug)
结局指标
主要结局
Incidence of dose limiting toxicity (DLT)
时间窗: 1 cycle (1 cycle = 28 days)
次要结局
- Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0(During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment)
研究者
研究点 (1)
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