INPHOG-NHL-25-03

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)”

PI : Dr. Prasanth Srinivasan

Institution : Cancer Institute Adyar, Chennai

Mail Id :prasanth230591@gmail.com

About the Study

This study evaluates a resource-adapted treatment approach for pediatric high-grade mature B-cell non-Hodgkin lymphoma in resource-limited settings. It assesses whether reduced-dose chemotherapy combined with Rituximab can improve survival outcomes while reducing treatment-related toxicity compared to standard chemotherapy. By balancing efficacy and safety, the study aims to generate evidence for a feasible and effective treatment protocol. In addition to survival, the study will prospectively evaluate acute toxicities and treatment abandonment, which are critical determinants of outcomes in such settings. Ultimately, it seeks to inform standardized, context-appropriate guidelines and help reduce disparities in outcomes between high- and low-resource settings.

Aim of the Study

To evaluate the safety and efficacy of a reduced-dose chemotherapy regimen combined with Rituximab in children and adolescents with newly diagnosed high-grade mature B-cell non-Hodgkin lymphoma, and to determine whether this resource-adapted approach can achieve favorable survival outcomes while reducing treatment-related toxicity in resource-limited settings.

Eligibility Criteria

Inclusion Criteria

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).
Group B and Group C - as per Inter-B-NHL Ritux 2010 trial risk stratification criteria.
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.
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].
Written informed consent from parents before enrolment. 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.

Exclusion Criteria

Children with active hepatitis B infection or carriers of hepatitis B virus.
Children with active hepatitis C infection or carriers of hepatitis C virus.
Children with HIV infection.
Children with primary immunodeficiency/inborn errors of immunity, chromosomal breakage syndrome and Down syndrome.
Children with prior organ transplantation/hematopoietic stem cell transplantation.
Children with previous malignancy of any type.
Children who have received past or current anti-cancer treatment except corticosteroids of less than 7 days.
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- ejection fraction < 45%.
Children with prior exposure to Rituximab.
Children who are allergic to rituximab.
Pregnant or breastfeeding patients.
Children assessed by treating physician as not fit for intensive chemotherapy.