EUCTR2011-006329-42-IT进行中（未招募）1 期
Short course of Bortezomib in anemic patients with refractory cold agglutinin disease
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点目标入组 25 人开始时间: 2012年10月30日最近更新:
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
- 25
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
- 性别
- All
入选标准
- •- Patients with chronic cold agglutinin disorder requiring transfusion or with a hemoglobin concentration below 10g/L determined at least monthly during the two months before entering the trial; - Failure of at least one previous treatment attempt; - Hemoglobin level assessment; - Cold agglutinin (CA) titer at 4°C of 64 or higher; - Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Presence of a concomitant lymphoproliferative disorder requiring specific treatment for reasons other than cold agglutinin related hemolytic anemia. - Preexisting peripheral neuropathy. - Known hypersensitivity to Bortezomib. - Non-cooperative behaviour or non-compliance. - Psychiatric diseases or conditions that might impair the ability to give informed consent. - Patients who are pregnant (women of childbearing potential must have a negative serum pregnancy test). Post-menopausal women must be amenorrhoic for at least 24 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
研究者
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