RPCEC00000251尚未招募4 期
Safety and effectiveness of CIMAbior® in patients with CD20-positive B-cell Non-Hodgkin Lymphoma. Phase IV
Center of Molecular Immunology0 个研究点开始时间: 2017年9月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients that fulfill diagnosis criteria
- •2. Patients who give their informed consent to participate, in writing.
- •3. Age greater than or equal to 18 years, of any gender.
- •4. Performance status less than or equal to 2 (ECOG).
- •5. Patients with laboratory parameters as detailed below:
- •-Hemoglobin= 100 g/L
- •-ALC = 3 x 109 cells/L
- •-ANC = 1,5x109 /L
- •-platelets =100 x 109/L,
- •-TGO/TGP= 2.5 time upper normal limits,
- •-Creatinine and bilirubin = 1.5 time upper normal limits.
- •-Hepatitis B and C negative antigens
排除标准
- •1. Pregnant or breast-feeding patients.
- •2. Patients with evidence of NHL dissemination to the central nervous system.
- •3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral .
- •4. Patients with uncontrolled intercurrent diseases, including, but not limited to: hypertension, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis, and psychiatric conditions that may limit adherence To the requirements of the test.
- •5. Patients with HIV positive serology or active hepatitis C or B virus infections.
- •6. Patients with previous malignancies, except carcinoma in situ of cervix or skin cancer (non-melanoma), correctly treated.
- •7. Patients with acute allergic conditions, history of severe allergic reactions or attributed to compounds of chemical or biological composition similar to the monoclonal antibody.
- •8. Patients who are receiving another product under investigation.
研究者
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