Study to verify whether using a reduced dose of chemotherapy is safe and effective among children with Non-Hodgkin Lymphoma

Phase 2

• Conditions: Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma

• Registration Number: CTRI/2024/06/069405
• Lead Sponsor: Cancer Institute WIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.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)

2.Group B and Group C - as per Inter-B-NHL Ritux 2010 trial risk stratification criteria

3.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.

4.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].

5.Written informed consent from parents before enrollment. 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 Hepatitis B, Hepatitis C, HIV, primary immunodeficiency, chromosomal breakage syndrome, Down syndrome, previous malignancy, prior exposure anti-cancer therapy, prior exposure to Rituximab, prior hematopoietic stem cell transplant or solid organ transplant.

Children allergic to Rituximab.

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

Pregnant or breastfeeding patients

Children assessed by treating physician as not fit for intensive chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate and compare the 1-year event free survival between the children receiving reduced dose chemotherapy and Rituximab (RD + RTX) and historical controls receiving standard chemotherapy.Timepoint: Baseline, Post prephase, Post Consolidation 1 for Group B and Post consolidation 2 for Group C and at end of treatment. <br/ ><br>Periodically after treatment completion till the end of study

Secondary Outcome Measures

Name	Time	Method
To compare the grade 3 & grade 4 acute toxicities between the children receiving reduced dose chemotherapy & Rituximab (RD + RTX) & historical controls receiving standard chemotherapy.Timepoint: D1 to D21 of each cycle;To compare the treatment abandonment rates between the children receiving reduced dose chemotherapy & Rituximab (RD + RTX) & historical controls receiving standard chemotherapy.Timepoint: Before every cycle till end of treatment;To estimate & compare the 1-year overall survival between the children receiving reduced dose chemotherapy & Rituximab (RD + RTX) & historical controls receiving standard chemotherapy.Timepoint: Baseline, Post prephase, Post Consolidation 1 for Group B & Post consolidation 2 for Group C & at end of treatment <br/ ><br>Periodically after treatment completion till the end of study