DRKS00000908已完成2 期
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic LeukemiaMulticenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
niversitäts-KinderklinikPädiatrische Hämatologie und Onkologie0 个研究点目标入组 90 人开始时间: 2012年3月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- one 至 18 Years（—）
- 性别
- All
入选标准
- •1. Newly diagnosed and histologically/immunohistologically or cytomorphologically/immunologically verified mature B-NHL or B-ALL (not: lymphoblastic lymphoma of precursor B-CELL type, protocol EURO-LB 02)
- •2. Immunological or immuno-histo-chemical proof of a CD20-expression of the lymphoma cells
- •3. Written informed consent and consent for the processing and disclosure of data by each patient and/or their legal guardian.
- •4. Diagnosis prior to 19th birthday.
- •5. Begin of protocol therapy within the duration of the study
- •6. Treatment in one of the participating study clinics
- •7. Contraception in women of child-bearing age
- •8. No participation in any other study with the exception of B-NHL BFM 04
- •9. Stratification according to stage, extent of resection, and initial LDH in the therapy arms R2, R3, or R4
- •10. Good general health; adequate liver, cardiac, and renal functions.
- •11. Existence of a lymphoma manifestation which is accessible for the assessment of response (measurement of size within 24 hours before application of Rituximab)
排除标准
- •Pregnant or nursing,
- •Allergies against proteins,
- •Known disease that would preclude protocol therapy with rituximab,
- •Significant therapy prior to protocol therapy
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