EUCTR2011-004835-30-DK进行中（未招募）1 期
Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5
Department of Medicine, Haugesund Hospital0 个研究点目标入组 50 人开始时间: 2012年11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
- 50
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
- •1. CAD diagnosis defined by the combination of –
- •a. Chronic hemolysis
- •b. Cold agglutinin titer > 64
- •c. Positive direct antiglobulin test when performed with polyspecific antiserum,
- •negative (or only weakly positive) with anti-IgG, and strongly positive with
- •2. The presence of a clonal B-cell lymphoproliferative disorder defined by –
- •a. Monoclonal band by serum electrophoresis with immunofixation, and/or
- •b. CD20 positive lymphocyte population with cellular ?/?-ratio higher than 3.5 or
- •less than 0.9, using flowcytometric immunophenotyping of bone marrow aspirates
- •3. Indication for therapy, i.e. significant anemia and/or considerable cold-induced
- •circulatory symptoms
- •4. Written informed consent
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. An aggressive lymphoma
- •2. Non-lymphatic malignant disease other than basal cell carcinoma of the skin. A
- •history of probably cured cancer is not an exclusion criterion.
- •3. Known HIV infection
- •4. Acute or chronic hepatitis B or C
- •5. Liver failure or active parenchymal liver disease. Bilirubin levels > 51 mol/L (3.0
- •mg/dL) when due to hepatic impairment. Elevated serum bilirubin level due to
- •hemolysis is not an exclusion criterion.
- •6. Pregnancy or breast-feeding
- •7. Patients of childbearing age who are not willing to use safe contraception during the
- •entire study period and 6 months following its cessation
- •8. All contraindications to the study drugs will be regarded as exclusion criteria.
- •9. Age < 18 years
- •10. Inability to cooperate
研究者
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