| 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
|
|
|
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
|
|
|
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. |