Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified
Conditions
Interventions
Intervention1: Gemcitabine Dexa Cisplatin
Nivolumab
: Cycle 1
Day 1 Gemcitabine Dexa Cisplatin
Day 8 Gemcitabine Nivolumab
Cycle 2
Day 1 Gemcitabine Cisplatin
Day 8 Gemcitabine Nivolumab
Control In
Sponsors
Christian Medical College Vellore Ranipet campus,
Eligibility
Inclusion criteria
Inclusion criteria: Patients with primary progressive or relapsed Hodgkin lymphoma Age above 18yrs Signed and dated written informed consent by start date of Screening visit in accordance with GCP
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Hepatitis B, C or HIV Ejection fraction less than 40% Total Bilirubin above 3mg% Serum Creatinine above 2mg% ECOG performance score above 3 History of auto-immune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment based on PET-CT findings Deauvile score. ased on our data and published literature, response to first salvage therapy is 40-50%. in chemo-refractory patients, we expected a response rate of 85% in the proposed study, hence a sample size of 19 patients in each arm will be adequate to detect a difference of 45% in response to therapy, with 5% significance and 80% power.Timepoint: After 49days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate Partial response rate PD-1 receptor saturation and T cell activation of peripheral blood T cells assessed by immunophenotyping prior to the 2nd cycle of chemotherapy Incidence of Grade 3 or above immune-related adverse events Response rates in bulk disease less than 10cm vs no bulk diseaseTimepoint: Day 49 | — |
Countries
India
Contacts
Public ContactAnu Korula Mithun Prakash Abraham
Christian Medical College Vellore Ranipet campus
Outcome results
None listed