Health Condition 1: C819- Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: 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/do
Sponsors
Dr Debasish Sahoo
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete metabolic remission (CMR) ratesTimepoint: 4 months (4 cycles of chemotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year event free survivalTimepoint: 2 years;2 year overall survivalTimepoint: 2 years;Safety of low dose nivolumab- AVDTimepoint: 6 months;Pharmacodynamics studies (Residual PD-1 expression, IL-2, IL-6, IFN, TNF)Timepoint: 1 month, 6 months | — |
Countries
India
Contacts
Public ContactDr Debasish Sahoo
AIIMS, Bhubaneswar
Outcome results
None listed