| CTRI Number |
CTRI/2025/03/082456 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of immune system to treat Hodgkin lymphoma in children |
|
Scientific Title of Study
|
Efficacy and safety of substitution of bleomycin by low dose nivolumab in ABVD (Doxorubicin plus Bleomycin plus Vinblastine plus Dacarbazine) backbone chemotherapy in newly diagnosed advanced stage pediatric Hodgkin Lymphoma: A phase II/III, multicentric, open label, randomized controlled trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debasish Sahoo |
| Designation |
Assistant Professor, Medical Oncology/ Hematology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room No 119, Hematology OPD, OPD Block, First Floor AIIMS, Bhubaneswar
Sijua, Dist- Khordha Odisha
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
8872028232 |
| Fax |
|
| Email |
debasish0712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasish Sahoo |
| Designation |
Assistant Professor, Medical Oncology/ Hematology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room No 119, Hematology OPD, OPD Block, First Floor AIIMS, Bhubaneswar
Sijua, Dist- Khordha Odisha
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
8872028232 |
| Fax |
|
| Email |
debasish0712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debasish Sahoo |
| Designation |
Assistant Professor, Medical Oncology/ Hematology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room No 119, Hematology OPD, OPD Block, First Floor AIIMS, Bhubaneswar
Sijua, Dist- Khordha Odisha
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
8872028232 |
| Fax |
|
| Email |
debasish0712@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Cancer Grid,
10th Floor, Homi Bhabha Block,Tata Memorial Hospital, Parel, Mumbai
India
Pin: 400012 |
|
|
Primary Sponsor
|
| Name |
Dr Debasish Sahoo |
| Address |
Room No 119, Hematology OPD, First Floor AIIMS, Bhubaneswar
Sijua, Dist- Khordha Odisha
Khordha
ORISSA
751019
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debasish Sahoo |
AIIMS, Bhubaneswar |
Room no 119,
Department of Medical Oncology/ Hematology
AIIMS, Bhubaneswar
Sijua, Dist- Khordha Odisha
Khordha
ORISSA
751019
India
Khordha
ORISSA |
8872028232
debasish0712@gmail.com |
| Dr Rachna Seth |
AIIMS, Delhi |
Room no 3043,
7th floor,
Mother and Child Block,
AIIMS, Delhi,
Ansari Nagar, New Delhi
110029
New Delhi
DELHI |
9971188687
drrachnaseth1967@gmail.com |
| Dr Siyaram Didel |
AIIMS, Jodhpur |
Room No 3091, Third floor
Medical College Building, Gate no 5
AIIMS, Jodhpur
Basni Industrial Area, Phase 2
Jodhpur, Rajasthan
342005
Jodhpur
RAJASTHAN |
9592079797
siyaram.didel@gmail.com |
| Dr Piali Mandal |
LHMC, New Delhi |
Room no 206, Third floor
Kalawati Saran Childrens Hospital,
C- 604, Connaught Circus, Bangla Sahib Rd, DIZ Area, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI |
9711630356
drpiali1982@gmail.com |
| Dr Shilpa Khanna Arora |
RML Hospital, New Dlehi |
Room no 201, Second floor,Department of Pediatrics, Guest House building, ABVIMS and RML Hospital, New Delhi
Pin 110001
New Delhi
DELHI |
9810068078
drshilpakhanna@gmail.com |
| Dr Sanjeev Khera |
RR Hospital, New Delhi |
Room no 104, first floor,
Army Research and Referral Hospital
Military Hospital Road, Dhaula Kuan, Delhi - 110010 (Near Dhaula Kuan Metro Station)
New Delhi
DELHI |
8192954481
KHERAKHERAKHERA@gmail.com |
| Dr Prashant Prabhakar |
Safdarjung Medical College, New Delhi |
Pediatrics HOD Office, Ward 21,
3rd Floor,
H Block,
VMMAC and Safdarjung Medical College,
New Delhi
New Delhi
DELHI |
8800719116
prashant15prabhakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| AIIMS, Bhubaneswar |
Approved |
| AIIMS, Delhi |
Submittted/Under Review |
| AIIMS, Jodhpur |
Submittted/Under Review |
| Army Hospital (Research and Referral) |
Submittted/Under Review |
| LHMC IEC |
Submittted/Under Review |
| RML Hospital, New Delhi |
Submittted/Under Review |
| Safdarjung Medical College |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adriamycin, Bleomycin, Vinblastine, Dacarbazine |
Bleomycin: 10 U/m2/dose IV, 2 weekly for 12 doses
Adriamycin: 25 mg/m2/dose IV, 2 weekly for 12 doses
Vinblastine: 6 mg/m2/dose IV, 2 weekly for 12 doses
Dacarbazine: 375 mg/m2/dose IV, 2 weekly for 12 doses |
| Intervention |
Low dose nivolumab- Adriamycin, Vinblastine, Dacrabazine |
Nivolumab: 0.75 mg/kg/dose IV 2 weekly for 12 doses
Adriamycin: 25 mg/m2/dose IV, 2 weekly for 12 doses
Vinblastine: 6 mg/m2/dose IV, 2 weekly for 12 doses
Dacarbazine: 375 mg/m2/dose IV, 2 weekly for 12 doses |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged less than 18 years with newly diagnosed classical Hodgkin lymphoma
2. Stage II B- IV disease
3. No prior treatment for disease (except steroids up to 7 days for superior mediastinal syndrome)
4. Informed consent given.
5. Patients in the reproductive age group and child bearing potential should agree for contraception or abstinence
6. Lansky performance score more than 20 |
|
| ExclusionCriteria |
| Details |
1. Cardiac dysfunction
2. Retroviral infection
3. Active Hepatitis B or C infection
4. Jaundice, with bilirubin more than 2 mg/dL or AST and ALT more than 5 times of upper limit of normal
5. Creatinine clearance less than 70 mL/ min/ 1.73 m2 (Calculated using Schwartz formula)
6. Past history of uveitis
7. Prior history or suspicion of autoimmune disorders
8. Underlying immunodeficiency disorders |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete metabolic remission (CMR) rates |
4 months (4 cycles of chemotherapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2 year event free survival |
2 years |
| 2 year overall survival |
2 years |
| Safety of low dose nivolumab- AVD |
6 months |
| Pharmacodynamics studies (Residual PD-1 expression, IL-2, IL-6, IFN, TNF) |
1 month, 6 months |
|
|
Target Sample Size
|
Total Sample Size="169"
Sample Size from India="169"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [debasish0712@gmail.com].
- For how long will this data be available start date provided 08-08-2030 and end date provided 08-08-2035?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|