EUCTR2006-000741-19-GB进行中（未招募）1 期
A phase I study of subcutaneous alemtuzumab in combination with oral fludarabine in previously untreated patients with chronic lymphocytic leukaemia. - FULLSCALE
HL NHS Trust0 个研究点目标入组 20 人开始时间: 2006年3月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •(1)At least 18 years old.
- •(2)Written informed consent.
- •(3)Previous confirmation of B-CLL with a characteristic immunophenotype on peripheral blood flow cytometry
- •(4)Creatinine and bilirubin or S-GOT/S-GPT <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
- •(5)Patient requires treatment for CLL as per the following criteria
- •-Rai stage III or IV
- •-Rai stage 0-II with at least one of the following
- •-Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
- •-Massive (>6cm below left costal margin) or progressive splenomegaly
- •-Progressive lymphocytosis with an increase >50% over a 2 month period or an anticipated lymphocyte doubling time of less than 6 months.
- •-Lymphocyte count > 100 x 109/l
- •-B symptoms
- •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
- •(1)Any previous therapy for CLL
- •(2)Known HIV, HBV, HCV positive
- •(3)Active infection
- •(4)Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies
- •(5)Use of prior investigational agents within 6 weeks
- •(6)Pregnancy or lactation
- •(7)CNS involvement with CLL
- •(8)Mantle cell lymphoma
- •(9)Other severe, concurrent diseases or mental disorders
- •(10)Active secondary malignancy or a history of malignancy during previous 5 years except treated cervical carcinoma or skin basalioma
研究者
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