NCT01242774已完成1 期
A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)
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
- 46
- 试验地点
- 6
- 主要终点
- Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.
研究概览
简要总结
This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk AML
- •= 20% bone marrow blasts via bone marrow aspiration or biopsy
- •The patient has not yet been treated for AML
- •1º or 2º AML patients with high-risk category features
- •ECOG PS = 2
- •Renal function and liver function limits.
排除标准
- •Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
- •Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS leukemia
- •Prior treatment with deacetylase inhibitors (DACi) including, panobinostat
- •Impaired cardiac function
- •Female patient who is pregnant or breast feeding
- •Male patient who is not willing to use a barrier method of contraception
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Panobinostat
Experimental
干预措施: Panobinostat (Drug)
结局指标
主要结局
Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.
时间窗: 1 year
次要结局
- To determine the number of patients who have safety and tolerability events(1 year)
- To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003)(1 year)
- To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments(1 year)
研究者
研究点 (6)
Loading locations...
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