JPRN-UMIN000021286已完成未知
Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (JPLSG B-NHL-14) - JPLSG B-NHL-14
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)0 个研究点目标入组 46 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 46
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
- 年龄范围
- 6months-old 至 216months-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Histology and staging disease - Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study - In phase II study (PMLBL) patients with CNS involvement are not eligible. General conditions - Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology. - Evidence of pregnancy or lactation period. - There will be no exclusion criteria based on organ function. Dosing guidelines for organ dysfunction are provided in annexe D1. Prior therapy Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total. Exclusion criteria related to rituximab - Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria). - Prior exposure to rituximab. - Severe active viral infection, especially hepatitis B. - Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of registration. Contact the national co- investigator for further advice if necessary. - Hepatitis B carrier status history of HBV or positive serology. A patient is considered as HBV carrier or to have (had) HBV infection in case of: - Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive, - Immunized and HBsAG and/or anti-HBc antibody positive. Others - Participation in another investigational drug clinical trial. - Patients who, for any reason, are not able to comply with the national legislation.
研究者
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