Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
Conditions
Interventions
Intervention1: Nivolumab
Adriamycin
Vinblastin
Dacarbazine
: Nivolumab 40mg X IV - OD X 4 DOSES
Adriamycin x 25mg/m2 IV OD x D1 and D15
Vinblastin x 6mg/m2 IV OD x D1 and D15
Dacarbazine x 375mg/m2 IV
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed advanced stage HL (as per GHSG criteria) with a PET scan done within previous one month. Age above 12years Advanced stage includes the following: Stage IIB with mediastinum-to-thorax ratio above 0.33 or above 10cm or extra-nodal disease Stage III A or B Stage IV A or B
Exclusion criteria
Exclusion criteria: Previous chemotherapy received (steroid pre-treatment is permitted) Pregnancy ECOG above 3 ECHO EF less than 50% Creatinine clearance above 30mL/mt Hepatitis B, C negative [Hep B, Hep C and HIV positive permitted if viral load is undetectable] History of autoimmune disease (autoimmune hepatitis, inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the early treatment failure (iPET2 with Deauville score above 3), disease progression, relapse or death at any time-point.Timepoint: after 2 weeks after 8 weeks after 1 year after years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)iPET-2 negative rate defined as FDG-PET/CT with a Deauville score of 1-3 [taken 2 weeks after completion of cycle 2B of chemotherapy] 2)Complete response rate after 6 cycles of chemotherapy defined as FDG-PET/CT with a Deauville score of 1-3 [taken 6-8 weeks after completion of cycle 6B] 3)Partial response rate defined as Deauville score 4 or 5 (reduced uptake compared with baseline and no new lesions) [taken 6-8 weeks after completion of cycle 6B] 4)Incidence and severity of adverse effects (haematological toxicity, immune-related adverse events and bleomycin toxicity) 5)Progression-free survival at 2 years defined as time to relapse/progression, death, or subsequent therapy (systemic cancer therapy or transplantation). 6)Overall survival at 2 years Timepoint: 2 weeks 6 to 8 weeks 3 months 6 months 12 months 24 months | — |
Countries
India
Contacts
Public ContactAnu Korula
Christian Medical College Ranipet Campus
Outcome results
None listed