EUCTR2005-003931-40-GB进行中(未招募)1 期
Phase ll Trial of Fludarabine & Cyclophosphamide followed by Thalidomide for Angioimmunoblastic Lymphoma - AIT
niversity College London0 个研究点目标入组 15 人开始时间: 2006年2月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients with a new diagnosis of angioimmunoblastic lymphoma and measurable (i.e. anatomically assessable) disease
- •WHO/ECOG performance status of 0, 1, or 2
- •Age >18 years
- •Negative pregnancy test if the patient is of childbearing potential (Women of child bearing potential must in addition be prepared to comply with the pregnancy testing schedule stipulatred by the risk management programme operated by the supplier of thalidomide)
- •Prepared to comply with the contraceptive measures stipulated by the thalidomide risk management scheme operated by the suppplier of the Thalidomide
- •Signed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior chemotherapy for AITL - however patients may have received a short course of steroids for rapid symptom control prior to enrolment
- •Active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy
- •Known seropositivity for HBV, HCV or HIV
- •Breastt feeding
- •Severe impairment of renal or liver function (defined as serum creatinine, bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal).
研究者
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