A Prospective Multi-Center Study on Practice, Clinical Outcomes, and Toxicities in Children with Mature B-cell Non-Hodgkin Lymphoma Treated with Rituximab-Based Chemotherapy Regimen in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 20
- 主要终点
- To study the effectiveness of Rituximab based chemotherapy in children with mature B-NHL
研究概览
简要总结
Non-Hodgkin lymphoma (NHL) is the third most common cancer in children, with mature B-cell NHL being a particularly aggressive but potentially curable subtype. While survival rates for this disease are high in resource-rich countries, outcomes in India remain lower, with significant challenges like treatment-related mortality, relapse, and treatment abandonment. Factors such as malnutrition, delayed diagnosis, and inadequate supportive care contribute to these poor outcomes. Rituximab, a monoclonal antibody targeting the CD20 protein on B-cells, has been shown in Western studies to improve survival when combined with chemotherapy. However, its use is associated with risks, including serious infections and immune system complications. While Rituximab has become the standard of care for high-risk B-cell NHL in children, there is limited data on its use in India. This study aims to collect detailed information on the use of Rituximab in pediatric mature B-cell NHL across multiple centers in India. The goal is to better understand the drug’s effects, including its benefits and risks, and to optimize treatment protocols to improve outcomes for children in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients more than 1 year and ≤18 years of age with newly diagnosed de novo mature B-cell lymphoma, including Burkitt lymphoma (BL), high-grade B-NHL not otherwise specified (BNHL NOS), and diffuse large B-cell lymphoma (DLBCL) with CD20-positive immunohistochemistry/ immunophenotyping and receiving rituximab as part of treatment.
排除标准
- •Children with previously diagnosed immunodeficiency state like people living with HIV and AIDS (PLHA) and immunodeficiency disorders.
- •Children with cancer predisposition syndromes.
- •3.Children with primary mediastinal B-cell lymphoma (PMBCL).
结局指标
主要结局
To study the effectiveness of Rituximab based chemotherapy in children with mature B-NHL
时间窗: The study will last for three years in which the treatment will be for 9 months and follow up for 36 months
including event-free survival (EFS) and overall survival (OS).
时间窗: The study will last for three years in which the treatment will be for 9 months and follow up for 36 months
次要结局
- 1. To document the use of Rituximab based chemotherapy in children with B NHL in India. To(record the number of doses of Rituximab used & variation in use of number of doses of)
研究者
Dr NIRMALYA ROY MOULIK
Tata Memorial Hospital
