CTRI/2024/12/078641 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On:
16/07/2026
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cohort Study
Study Design
Single Arm Study
Public Title of Study
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)
Scientific Title of Study
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
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr NIRMALYA ROY MOULIK
Designation
Professor Pediatric Medical Oncology
Affiliation
Tata Memorial Hospital
Address
Professor Pediatric Medical Oncology R. no. HBB-1113, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 OPD -88 GROUND FLOOR , MAIN BUILDING,Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 Mumbai MAHARASHTRA 400012 India
Phone
7045991385
Fax
Email
nirmalyaroymoulik@gmail.com
Details of Contact Person Scientific Query
Name
Divyang Harjani
Designation
Clinical Research Coordinator
Affiliation
Tata Memorial Hospital
Address
Pediatric Medical oncology Room no.HBB-1113, 11th Floor, Homi Bhabha Block Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 Pediatric Medical oncology Room no.HBB-1113, 11th Floor, Homi Bhabha Block Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 Mumbai MAHARASHTRA Pin-400012 India
Phone
7976347336
Fax
Email
divyangharjani24tmh@gmail.com
Details of Contact Person Public Query
Name
Divyang Harjani
Designation
Clinical Research Coordinator
Affiliation
Tata Memorial Hospital
Address
Pediatric Medical oncology Room no.HBB-1113, 11th Floor, Homi Bhabha Block Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 Pediatric Medical oncology Room no.HBB-1113, 11th Floor, Homi Bhabha Block Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012 Mumbai MAHARASHTRA Pin-400012 India
Phone
7976347336
Fax
Email
divyangharjani24tmh@gmail.com
Source of Monetary or Material Support
Tata Memorial Hospital. Dr. Earnest Borges Road. Parel, Mumbai, INDIA Pin-400012
Primary Sponsor
Name
Dr.Nirmalya Roy Moulik, Tata Memorial Hospital. Parel. Mumbai. Pin-400012
Address
R. no. HBB-1113, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital. Dr. Earnest Borges Road. Parel. Mumbai. Pin-400012
NICU and ward 5, pediatric hematology oncology, Pune-Satara Road, Dhankwadi Pune MAHARASHTRA
9823162762
drvibhabafna@gmail.com
DrShrutiKakkar
ChristianMedicalCollege&HospitalLudhiana141 008,Punjab, India
4th Floor, Department of Clinical Haematology, Haemato-Oncology & Bone Marrow (Stem Cell) Transplantation, Christian Medical College & Hospital, Ludhiana – 141 008, Punjab, India
Ludhiana PUNJAB
8283878361
shruti.kakkar@cmcludhiana.in
Dr Gurpreet Singh
Dayanand Medical College & Hospital
Department of pediatrics ,second floor ,ward no.209, Civil Lines, Tagore Nagar Ludhiana PUNJAB
7888365923
dr.gurpreetsingh@yahoo.in
DrVelagalaSwethaVenkatareddy
HBCH RC Ethics Committee
vizag Visakhapatnam ANDHRA PRADESH
9611341809
drvswethareddy@gmail.com
Dr Raghwesh Ranjan
Homi bhabha cancer Hospital, Varanasi
Ghanti Mill road, Lahartara, Old Loco colony, Shivpurwa, Varanasi, Uttar Pradesh-221002 Varanasi UTTAR PRADESH
9660417130
raghavranjan007@gmail.com
Dr Amita Mahajan
Indraprastha Apollo Hospital
NH-19,Sarita Vihar, Jasola Vihar, New Delhi, Delhi 110020 Central DELHI
919811025001
ecbmrapollodelhi@gmail.com
DrEmine A Rahiman
Kasturba Medical College,Manipal,Karnataka-
Department of Pediatric Oncology,Women and child block,ground floor Udupi KARNATAKA
919878169259
emine.rahiman@manipal.edu
Dr Nishant Verma
King Georges Medical University
Pediatric Hematology Oncology Unit, Department of Pediatrics, KGMU, Shahmina Road, Chowk, Lucknow, PIN 226003 Lucknow UTTAR PRADESH
Sir Ganga Ram Hospital Rd, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 110060 Central DELHI
98107 05449
Manaskalra27@gmail.com
Dr Ashwini A
Sri Ramachandra Institute of Higher Education and Research
Department of Pediatric Hematooncology, No 1
Ramachandra Nagar
Porur
Chennai 600116 Thiruvallur TAMIL NADU
9994590218
ashwini.am3010@gmail.com
DrVandana Bharadwaj
St Johns Medical College Hospital
Department of Pediatric Hematology Oncology & BMT
St Johns Medical College Hospital
Sarjapur Road,
Karnataka State
Bangalore District
560034 Bangalore KARNATAKA
9902880979
vandana.b@stjohns.in
Dr Pritam Singha Roy
TATA MEDICAL CENTER, KOLKATA
Department of Pediatric Hematology Oncology, Phase II, Second Floor, 14, Major Arterial Road (E-W), Action Area I, Rajarhat, Newtown, Kolkata - 700160 Kolkata WEST BENGAL
9501783136
pritamsingha.roy@tmckolkata.com
DRNIRMALYA ROY MOULIK
TATA MEMORIAL HOSPITAL
Pediatric Medical Oncology Room.no. HBB-1113, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital. Dr. Earnest Borges Road. Parel, Mumbai. Pin-400012 Mumbai MAHARASHTRA
7045991385
nirmalyaroymoulik@gmail.com
Dr Chinmay Doctor
The Gujarat Cancer and Research Institute Civil Hospital campus Asarwa
Pediatric OPD
Block A Ahmedabad 380016 Ahmadabad GUJARAT
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.
ExclusionCriteria
Details
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)
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To study the effectiveness of Rituximab based chemotherapy in children with mature B-NHL
including event-free survival (EFS) and overall survival (OS).
The study will last for three years in which the treatment will be for 9 months and follow up for 36 months
Secondary Outcome
Outcome
TimePoints
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.
The study will last for three years in which the treatment will be for 9 months & follow up for 36 months
Target Sample Size
Total Sample Size="150" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
15/01/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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.