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

Phase II Study of Bendamustine and fixed dose Nivolumab in Children and young adults with Relapsed or Refractory Hodgkin Lymphoma - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088241

Enrollment

Registered

2025-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C81- Hodgkin lymphoma

Interventions

Intervention1: Bendamustine: Bendamustine is an alkylating agent with antineoplastic activity, used as chemotherapy. Intervention2: Nivolumab: Nivolumab is an immune checkpoint inhibitor (PD-1 blockin

Eligibility

Inclusion criteria

Inclusion criteria: 1. All diagnosed cases of first or subsequent relapse and refractory Hodgkins Lymphoma proven by histopathology 2. Written informed consent according to institutional guidelines

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 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

Measure	Time frame
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. Timepoint: 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	—

Measure

Time frame

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. Timepoint: 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

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Countries

India

Contacts

Public ContactDr Shyam Srinivasan

Tata Memorial Hospital

srinivas.shyam@gmail.com9619983999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026