FindTrial
Sign In

Study Examining the Effects of Using Rituximab Targeted Immune Therapy Along With Chemotherapy in Children With B-Cell Non-Hodgkin Lymphoma (a Relatively Common Cancer of Lymph Glands in Children)

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 - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/078641
Enrollment
150
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C859- Non-Hodgkin lymphoma, unspecified Health Condition 2: C858- Other specified types of non-Hodgkin lymphoma

Interventions

Control Intervention1: NA: NA

Sponsors

Dr.Nirmalya Roy Moulik, Tata Memorial Hospital. Parel. Mumbai. Pin-400012
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 1. Children with previously diagnosed immunodeficiency state like people living with HIV and AIDS (PLHA) and immunodeficiency disorders. 2. Children with cancer predisposition syndromes. 3.Children with primary mediastinal B-cell lymphoma (PMBCL)

Design outcomes

Primary

MeasureTime frame
To study the effectiveness of Rituximab based chemotherapy in children with mature B-NHL including event-free survival (EFS) and overall survival (OS).Timepoint: The study will last for three years in which the treatment will be for 9 months and follow up for 36 months—

Secondary

MeasureTime frame
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 Rituximab & chemotherapy dose modifications by various centres in treatment of children with B NHL. 2. To estimate the incidence of infusion/ allergic/ anaphylactic reactions to Rituximab infusion. 3. To estimate the duration of myelosuppression in children with mature B-NHL treated with Rituximab + chemotherapy. 4. To estimate the incidence of infective complications including viral infections during & after treatment. 5. To estimate the incidence of organ dysfunction/ failure in children with B NHL treated with Rituximab + chemotherapy. Timepoint: The study will last for three years in which the treatment will be for 9 months & follow up for 36 months—

Countries

India

Contacts

Public ContactDivyang Harjani

Tata Memorial Hospital

divyangharjani24tmh@gmail.com7976347336

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026