INPHOG-NHL-24-02

A prospective multi-centric study on practice, clinical outcomes, and toxicities in children with mature B-cell non-Hodgkin lymphoma treated with a Rituximab-based chemotherapy regimen

PI : Dr. Nirmalya Roy Moulik

Institution : Tata Memorial Hospital, Mumbai

Mail Id :roymoulik@gmail.com

About the Study

This is a prospective, multicentric observational study being conducted across INPHOG centers and other childhood cancer units in India. The study aims to generate real-world evidence on the use, safety, toxicities, and clinical outcomes of Rituximab-based chemotherapy in children with mature B-cell Non-Hodgkin lymphoma (B-NHL).

Despite improvements in survival, outcomes in India remain inferior to high-income countries due to treatment-related toxicity, infections, and variability in clinical practice. With increasing use of Rituximab, there is a critical need to systematically document its effectiveness, toxicity profile, and treatment modifications in the Indian setting.

Aim of the Study

To prospectively evaluate the clinical outcomes, toxicity profile, and immunological impact of Rituximab-based chemotherapy in children with mature B-cell Non-Hodgkin lymphoma in India. .

Eligibility Criteria

Inclusion Criteria

Children aged >1 year to ≤18 years
Newly diagnosed de novo mature B-cell Non-Hodgkin lymphoma, including :
1. Burkitt lymphoma (BL).
2. Diffuse large B-cell lymphoma (DLBCL).
3. B-NHL not otherwise specified (BNHL NOS).
CD20-positive disease confirmed by immunohistochemistry / immunophenotyping.
Patients receiving Rituximab as part of their chemotherapy regimen.

Exclusion Criteria

Children with pre-existing immunodeficiency, including :
1. HIV / AIDS (PLHA).
2. Known primary immunodeficiency disorders.
Children with cancer predisposition syndromes.
Patients diagnosed with Primary Mediastinal B-cell Lymphoma (PMBCL).