EUCTR2011-005474-38-BE进行中（未招募）不适用
89Zr-Rituximab PET/CT-Imaging and Dosimetry and 90Y-Rituximab Radioimmunotherapy in CD20+ B-Cell lymphoma - YZIRIT
Institut Jules Bordet0 个研究点开始时间: 2011年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed (according to the REAL/WHO classification) CD20 positive lymphomas
- •Patients with a PR or PD
- •Failed at least one regimen of standard treatment/chemotherapy
- •Age 18 years or older
- •World Health Organization (WHO) performance status of 0 to 2
- •Absolute Neutrophil Count (ANC) of 1.5 x 109/L or higher
- •Haemoglobin (Hb) of 9 g/dl or higher
- •Platelet count of 100 x 109/L or higher
- •Life expectancy of at least 6 months
- •Written informed consent obtained according to local guidelines
- •For patients with = 3 prior cytotoxic treatment regimens and/or patients previously treated with stem cell transplantation, a bone marrow or peripheral blood stem cell harvest is mandatory to rescue unexpected marrow toxicity from the procedure.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients who have not recovered from the toxic effects of previous treatment
- •Any other uncontrolled malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •Patients with known HIV positivity
- •Patients who are positive for HCV, HbsAG or other active infection uncontrolled by treatment
- •Patients with abnormal liver function: total bilirubin > 2 x ULN or ALT > 3 x ULN
- •Patients with abnormal renal function: serum creatinine> 2 x ULN
- •Known anti-chimeric antibody (HACA) reactivity or hypersensitivity to murine antibodies or proteins
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
- •Concurrent severe and/or uncontrolled medical disease (ie. uncontrolled diabetes, conges¬tive heart failure, myocardial infarction within 6 months of the study, unstable and uncon¬trolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.
- •Patients who received investigational drugs less than 4 weeks before entry in this study or who have not as yet recovered from the toxic effects of such therapy
- •Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment
- •Patients with a history of psychological illness or condition which could interfere with his ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- •Patients unwilling or unable to comply with the protocol
研究者
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