ISRCTN26640234已完成不适用
Epstein-barr virus (EBV)-specific immune effector cell (EBV-IE) for pre-emptive/preventive and therapeutic treatment of EBV-related diseases such as lymphoproliferative disorder (LPD) and post-transplantation lymphoproliferative disorder (PTLD)
Vectorite Biomedica Inc. (Taiwan)0 个研究点目标入组 12 人开始时间: 2009年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The participants should meet at least one of the following conditions:
- •1.1. Bone marrow transplant (BMT) or solid organ transplant (SOT) patient:
- •1.1.1. High-risk subject of developing LPD: donor is EBV sero-positive (EBV-VCA IgG+) while subject is EBV sero-negative (EBV-VCA IgG-)
- •1.1.2. The subject has history of EBV-LPD or EBV-related malignancy
- •1.1.3. The subject with EBV-LPD and is not adaptable for conventional treatment
- •1.1.4. The subject shows EBV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
- •1.1.5. The subject with the symptoms of EBV reactivation (fever, diarrhoea or lymphadenopathy) and confirmed by biopsy examination, regardless of the EBV level
- •1.2. EBV-infected subjects without BMT/SOT:
- •1.2.1. Subject develops EBV-LPD and not suitable for conventional treatment
- •1.2.2. The subject shows EBV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
- •1.2.3. The subject with the symptoms of EBV reactivation (fever, diarrhoea or lymphadenopathy) and confirmed by biopsy examination, regardless of the EBV level
- •2. Aged less than or equal to 65 years old
- •3. Subject blood:
- •3.1. White blood cell count (WBC) greater than or equal to 3500/µl
- •3.2. Blood lymphocytes greater than or equal to 750/µl
- •4. Liver and kidney function:
- •4.1. Creatinine less than or equal to 1.25 times of upper limit
- •4.2. Bilirubin less than or equal to 1.5 times of upper limit
- •4.3. Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times of upper limit
- •4.4. Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times of upper limit
- •5. Donor condition:
- •5.1. No chemo- or radiotherapy within 4 weeks of blood collection; no steroid use within 1 week of blood collection
- •5.2. WBC greater than or equal to 3500/µl
- •5.3. Lymphocytes greater than or equal to 750/µl
- •6. Signed informed consent
排除标准
- •1. Donor or recipient is positive for hepatitis C virus (HCV) (HCV antibody), human immunodeficiency virus (HIV) (HIV antibody) or tuberculosis (TB) (TB culture)
- •2. Recipient develops grade IV graft-versus-host disease (GvHD)
- •3. Recipient is albumin-intolerant
- •4. Recipient life expectancy is less than 8 weeks
- •5. Recipient received alternative cell therapy within 30 days
- •6. Recipient is pregnant
研究者
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