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CTRI Number  CTRI/2024/11/076407 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Immunotherapy in Childhood with Hodgkin Lymphoma- Real World Data 
Scientific Title of Study   Immunotherapy in Children and Adolescents with Hodgkin Lymphoma Real World Data 
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 Amita Mahajan 
Designation  Senior Consultant 
Affiliation  Indraprastha Apollo Hospitals 
Address  Department of Pediatrics, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi, 110076

South
DELHI
110076
India 
Phone  9810734137  
Fax    
Email  mahajanamita1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amita Mahajan 
Designation  Senior Consultant 
Affiliation  Indraprastha Apollo Hospitals 
Address  Department of Pediatrics, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi, 110076

South
DELHI
110076
India 
Phone  9810734137  
Fax    
Email  mahajanamita1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amita Mahajan 
Designation  Senior Consultant 
Affiliation  Indraprastha Apollo Hospitals 
Address  Department of Pediatrics, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi, 110076

South
DELHI
110076
India 
Phone  9810734137  
Fax    
Email  mahajanamita1@gmail.com  
 
Source of Monetary or Material Support  
CanKids KidsCan J161/A Gautam Nagar Behind Indian Oil Building New Delhi-110049 
 
Primary Sponsor  
Name  CanKids KidsCan 
Address  J-1161/A Gautam Nagar, Near Green Park Metro station, New Delhi, 110049 
Type of Sponsor  Other [Social Sector (NGO)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramya Uppuluri  Apollo Hospital  Department of Pediatric Oncology, No 21, Greams Lane, Off Greams Road, Chennai
Chennai
TAMIL NADU 
8939710906

ramya.december@gmail.com 
Dr Amita Mahajan  Indraprastha Apollo Hospitals  Department of Pediatric Hematology Oncology, Delhi Mathura Road, Sarita Vihar, New Delhi, 110076
South
DELHI 
9810734137

mahajanamita1@gmail.com 
Dr Rayaz Ahmed Khalid  Max Super Speciality Hospital  Department of Pediatric Oncology, 1 2 press enclave marg, saket institutional area, New Delhi
New Delhi
DELHI 
8826033518

Rayaz.khalid@maxhealthcare.com 
Dr Payal Malhotra  Rajiv Gandhi Cancer Institute and Research Centre  Department of Pediatric Oncology, Rohini, Sector V, New delhi
New Delhi
DELHI 
8447902048

drpayalsharma18@gmail.com 
Dr Manas Kalra  Sir Ganga Ram Hospital  Department of Pediatric Oncology, Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 110060
New Delhi
DELHI 
9958255228

manaskalra27@gmail.com 
Dr Reghu  Tata Medical Centre  Department of Pediatric Oncology, 14 Mar (E-W), New Town, Rajarhat, kolkata
Kolkata
WEST BENGAL 
9349323732

reghu.ks@tmckolkata.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Instituational Ethics Committee  Submittted/Under Review 
Instituational Ethics Committee (IEC), Devki Devi foundation  Submittted/Under Review 
Instituational Ethics Committee-Bio Medical Research, Apollo Hospitals, Chennai  Approved 
Instituational Ethics Committee-Biomedical Research Indraprastha Apollo Hospital, Delhi  Approved 
Institutional Review BoardEC  Approved 
Rajiv Gandhi Cancer Institute and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  1. Children aged between 0-21 years who has received agents Brentuximab, Nivolumomab, Pembroluzimab from January 2018- December 2023
2. Full Records and follow-up should be available 
 
ExclusionCriteria 
Details  1. Full records unavailable.
2. Follow-up details unavailable 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
response of various immunotherapeutic agents in children and adolescents with HL in India  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
To document the challenges in terms of response evaluation to these agents  1 Years 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/11/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

The outcomes of Hodgkin lymphoma in children and adolescents who receive optimal treatment approach in excess of 90% in patients with early stage disease and 80% in patients with advanced stage disease. Nevertheless, 10-20% patients either have refractory disease or have a recurrence.  A significant proportion of them can be effectively salvaged with further chemotherapy/ immunotherapy including high dose chemotherapy with stem cell rescue.

The management of Hodgkin Lymphoma is currently undergoing a major paradigm shift with increasing role of immunotherapy especially for patients with relapsed/ refractory disease but also in frontline setting primarily with the specific purpose of improving outcomes with limited toxicity both in the short and long-term.  The precise place of immunotherapy (anti CD30 monoclonal antibody and PDL1 blockade) in children is being defined in prospective collaborative studies by various consortia.

These novel agents, however, come at a considerable cost and our it is unclear whether there will be novel toxicities that may emerge with increasing cumulative experience. In low-middle-income countries, these modalities are largely reserved for relapsed/refractory disease frequently in off-label settings. For e.g., nivolumomab is currently licensed for post ASCT relapse but economic considerations mean that it may be used in pre-transplant settings as well to achieve response and allow for ASCT to be done. Experience at individual centers is limited. It is therefore, vital that we understand and collate real world data especially the  response rates documented in various clinical settings and the adverse events observed as we work towards identifying optimal strategies in our settings for all patients.

This simple retrospective study aims to capture the above.

 
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