| CTRI Number |
CTRI/2025/06/088241 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical research conducted to study the tolerance and efficacy of two medicines namely Bendamustine and Nivolumab which are used for treatment of relapse or non-responsive type of Hodgkins Lymphoma (a type of blood cancer) in children and young adults |
|
Scientific Title of Study
|
Phase II Study of Bendamustine and fixed dose Nivolumab in Children and young adults with Relapsed or Refractory Hodgkin Lymphoma |
| 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 Shyam Srinivasan |
| Designation |
Assistant Professor, Medical Oncology (Pediatrics) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology (Pediatric), HBB-1113, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619983999 |
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Srinivasan |
| Designation |
Assistant Professor, Medical Oncology (Pediatrics) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology (Pediatric), HBB-1113, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619983999 |
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Srinivasan |
| Designation |
Assistant Professor, Medical Oncology (Pediatrics) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology (Pediatric), HBB-1113, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619983999 |
| Fax |
|
| Email |
srinivas.shyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre
Dr. Ernest Borges Road, Parel, Mumbai-400012, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Shyam Srinivasan |
| Address |
Department of Medical Oncology (Pediatric), HBB-1113, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Road, Parel, Mumbai |
| Type of Sponsor |
Other [Self-Intramural] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maharshi Trivedi |
Gujarat Cancer and Research Institute |
Pediatric Oncology Unit Room no. 102,A Block, Civil Hospital Campus, Asarwa, Ahmedabad-380 016
Ahmadabad
GUJARAT |
9408716111
maharshi.trivedi@gcriindia.org |
| Dr Amita Mahajan |
Indraprastha Apollo Hospital |
ARI Main Building,NH-19, Sarita Vihar, Mathura Road, New Delhi - 110076
South
DELHI |
9810734137
mahajanamita1@gmail.com |
| Dr Payal Malhotra |
Rajiv Gandhi Cancer Institute and Research Centre |
Ground Floor, D- Block, Room No. 3075, Department of Pediatric Hematology Oncology, D-18 , Sector-5, Sir Chotu Ram Marg, Rohini, Delhi- 110085
North West
DELHI |
01147022255
drpayalsharma18@gmail.com |
| Dr Shyam Srinivasan |
Tata Memorial Hospital |
Department of Medical Oncology (Pediatric), HBB-1113, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA |
9619983999
srinivas.shyam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| GCRI/GCS Ethics Committee |
Approved |
| Institutional Ethics Committee-Biomedical Research |
Approved |
| Institutional Ethics Committee-I, IEC Ofiice, Dr E Borges Marg, Parel East, Mumbai 400012 |
Approved |
| RGCI_Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81||Hodgkin lymphoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bendamustine |
Bendamustine is an alkylating agent with antineoplastic activity, used as chemotherapy. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nivolumab |
Nivolumab is an immune checkpoint inhibitor (PD-1 blocking monoclonal antibody) used as immunotherapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. All diagnosed cases of first or subsequent relapse and refractory Hodgkins Lymphoma proven by histopathology
2. Written informed consent according to institutional guidelines |
|
| ExclusionCriteria |
| Details |
1. Participants more than 25 years of age
2. Subjects with nodular lymphocyte-predominant HL
3. HL previously documented to be nonresponsive to nivolumab
4. Prior radiation therapy within 3 weeks, or chest radiation less than or equal to 24 weeks prior to first cycle of therapy
5. Seropositive for hepatitis B, hepatitis C, and HIV
6. History of or active autoimmune disease
7. Subjects with active interstitial pneumonitis
8. History of allergy to study drug components
9. Patients with renal, liver or cardiac compromise as determined by the clinician |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the safety and efficacy of the combination of bendamustine and fixed dose nivolumab among children and young adults with relapsed or refractory Hodgkin Lymphoma.
|
Toxicities during and after 3 cycles of nivolumab and bendamustine
PET-CT after 3rd cycle to assess Complete Metabolic Response (Deauville Score 1–3)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate the feasibility of High-Dose Chemotherapy/ Autologous Bone Marrow Transplant in patients with high-risk relapsed or refractory Hodgkin Lymphoma.
2. To estimate the feasibility and efficacy of delivering nivolumab maintenance among high-risk relapsed or refractory Hodgkin Lymphoma.
3. To estimate the event free survival and overall survival in children and young adults with relapsed or refractory Hodgkin Lymphoma treated with fixed dose nivolumab and bendamustine.
|
1. After Cycle 3, Metabolic Response will be assessment
2. Approximately 45 days after High-Dose Chemotherapy with Autologous Stem Cell Transplantation or after Radiotherapy
3. 3 years from completion of the study intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| 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
|
Hodgkin lymphoma, also known as Hodgkin disease, is a type of cancer that develops in the lymphatic system. Children and young adults with relapsed or refractory Hodgkin Lymphoma are difficult to treat. Previously the treatment used to be chemotherapy. Multiple studies have shown that chemotherapy is not very effective to cure the disease. New drugs which are based on the principle of immunotherapy are being studied. One such drug is Nivolumab which targets specific proteins on the cancer cells. Multiple studies have shown that Nivolumab when used alone or in combination with other chemotherapy drugs are effective for disease control and also have minimal side effects. In this study we want to learn the efficacy of Nivolumab and Bendamustine in causing remission in patients with relapsed or refractory Hodgkin lymphoma. This trial is conducted to answer two questions; 1) How effective is the drug combination of Nivolumab and Bendamustine in producing remission in relapsed and refractory Hodgkins lymphoma 2) What are the toxicities associated with this drug combination. |