Health Condition 1: C819- Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: Salvage chemotherapy with low dose nivolumab: 3 cycles of salvage chemotherapy (investigators choice from the list) with low-dose nivolumab (40 mg X 2 doses givne 6 weeks apart).
Contro
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Relapsed/ refractory Hodgkins Lymphoma having previously received at least 1-2 lines of standard chemotherapy. 2. Demonstrated disease recurrence or progression or refractoriness by clear evidence on PET-CT or other imaging studies with or without biopsy confirmation 3. ECOG performance status 0 to 1 4. Written informed consent for adults over 18 years of age and consent from parents/ legal guardians for those below 18. Written assent for those 12-18 years and verbal assent for those 7-12 years old. 5. Negative urine/ serum pregnancy test in women of childbearing potential (WOCBP) 6. Female patients in the reproductive age group MUST AGREE TO use suitable contraception during therapy 7. Acceptable bone marrow and organ function at screening 8. Measurable disease must be present either on physical examination or imaging studies
Exclusion criteria
Exclusion criteria: 1. Any anti-cancer therapy (other than palliative radiation and steroids) within the last three weeks 2. CNS involvement by disease 3. Inter-current severe illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction would preclude safe administration of the protocol treatment. 4. Prior therapy with immune checkpoint inhibitors 5. Prior therapy with auto SCT/ alloSCT 6. Human Immunodeficiency Virus (HIV) infection/and/or Anti-retroviral therapy and/or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study). 7. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study). 8. Uncontrolled medical conditions, including but not limited to uncontrolled diabetes mellitus and hypertension which may interfere with the safe delivery of salvage chemotherapy or immune therapy. 9. History of significant autoimmune or connective tissue disorders, which may be exacerbated by the use of nivolumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate in all evaluable patientsTimepoint: 9 weeks from start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free survivalTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactPrasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed