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.
● Principal Investigator: Dr Nirmalya Roy Moulik
● To prospectively study the clinical, laboratory, and immunological parameters/outcomes along with toxicities encountered in children with mature B-NHL treated with a rituximab-based chemotherapy regimen.
● 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.
● Exclusion Criteria:
● Children with previously diagnosed immunodeficiency states like people living with HIV and AIDS (PLHA) and immunodeficiency disorders.
● Children with cancer predisposition syndromes.
● Children with primary mediastinal B-cell lymphoma (PMBCL
● To study the effectiveness of Rituximab based chemotherapy in children with mature B-NHL including event-free survival (EFS) and overall survival (OS).
● 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 Rituximab & chemotherapy dose modifications by various centres in treatment of children with NHL.
● To estimate the incidence of infusion/ allergic/ anaphylactic reactions to Rituximab infusion.
● To estimate the duration of myelosuppression in children with mature B-NHL treated with Rituximab + chemotherapy.
● To estimate the incidence of infective complications including viral infections during & after treatment.
● To estimate the incidence of organ dysfunction/ failure in children with B NHL treated with Rituximab + chemotherapy.
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.