CTRI/2024/06/069405尚未招募2 期
Safety and Efficacy of Reduced dose chemotherapy in children and adolescents with high grade mature B Non-Hodgkin Lymphoma – A Prospective Multicenter Phase II Single Arm Study - RED X – B NHL Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •1.Children aged 1-18 years with newly diagnosed CD20 positive high grade mature B Non-Hodgkin lymphoma (Burkitt lymphoma, DLBCL & High-grade B-NHL – DEL/DHL/TEL/THL/NOS)
- •2.Group B and Group C - as per Inter-B-NHL Ritux 2010 trial risk stratification criteria
- •3.Lansky play performance score of 60 or more for less than 16 years. Eastern Cooperative Oncology Group performance status of 0, 1, or 2 for 16-18 years.
- •4.Adequate organ function as confirmed by laboratory investigations within two weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within four times upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN].
- •5.Written informed consent from parents before enrollment. Children above 7-12 years of age will need to provide verbal assent. Children between 13 and 18 years of age must provide written assent.
排除标准
- •Children with Hepatitis B, Hepatitis C, HIV, primary immunodeficiency, chromosomal breakage syndrome, Down syndrome, previous malignancy, prior exposure anti-cancer therapy, prior exposure to Rituximab, prior hematopoietic stem cell transplant or solid organ transplant.
- •Children allergic to Rituximab.
- •Children with B-lymphoblastic lymphoma, follicular lymphoma, MALT, nodular marginal zone lymphoma, mantle cell lymphoma and primary mediastinal B cell lymphoma
- •Children with cardiac dysfunction
- •Pregnant or breastfeeding patients
- •Children assessed by treating physician as not fit for intensive chemotherapy
研究者
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