ACTRN12612000746831招募中1 期
A Phase I/II trial to determine the Safety, Toxicity and Efficacy of Iodine-131-Rituximab and the Histone Deacetylase Inhibitor Panobinostat in Relapsed and Refractory Indolent B-cell Lymphoma
Peter MacCallum Cancer Centre0 个研究点目标入组 30 人开始时间: 2012年7月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically confirmed relapsed indolent B-cell NHL.
- •Measurable disease by CT criteria.
- •One or more lines of previous therapy.
- •Age >18 years.
- •ECOG performance status <2.
- •Protocol defined adequate bone marrow function, serum electrolyte levels and hepatic function.
- •Written informed consent.
- •A negative serum pregnancy test in women.
排除标准
- •Exclusion Criteria:
- •Chemotherapy or radiotherapy <4 weeks previously.
- •Previous HDACi (excluding prior valproate therapy).
- •Stable platelet count<100x109/L and neutrophils<1.5x109/L.
- •Previously diagnosed myelodysplasia (MDS).
- •Another malignancy <3 years previously
- •Major surgery less than or equal to 2 weeks prior to starting study drug.
- •Patients with evidence of significant bleeding.
- •Unresolved diarrhoea.
- •A protocol defined history of significant heart disease
- •Use of medications at risk of causing prolonged QT interval.
- •Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of panobinostat
- •Any concurrent severe and/or uncontrolled medical conditions.
- •Hepatitis B, C, or HIV positivity.
- •Pregnant or breast feeding women.
研究者
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