Health Condition 1: C819- Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: Low dose Nivolumab: Transplant ineligible â?? For patients who are considered ineligible for intensive chemotherapy and autologous stem cell transplant (co-morbidities, elderly), our cu
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: i.Patients with primary progressive or relapsed Hodgkin lymphoma ii.Signed and dated written informed consent by start date of Screening visit in accordance with GCP
Exclusion criteria
Exclusion criteria: i. Age ii. Pregnancy or lactation iii. Hepatitis B, C or HIV iv. Ejection fraction v. Total Bilirubin >3mg% vi. Serum Creatinine > 2mg% vii. ECOG performance score >3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: 2 year relapse-free survival Cohort 2: Deauville score of 3 (End-of â??therapy PET [EOT PET]) Response to therapy on PET scan will be categorised as per the standard reporting Deauville criteria Deauville score 1-3 â?? Complete response at EOT-PET Deauville score 4 â?? Partial response at EOT-PET Deauville score 5 - Residual/progressive disease at EOT PETTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Complete response rate at end-of-induction (DS 3) Incidence of Grade 3 or above immune-related adverse events Cohort 2: Incidence of Grade 3 or above immune-related adverse events Adequate stem cell mobilization cells per kg body weight in a maximum of 2 collections) 2 year relapse-free survival Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactAnu Korula
Christian Medical College
Outcome results
None listed