The main objective of this project is to prove the efficacy and safety of Nivolumab used as an standard dose of 40mg ( as the lowest available presentation) in combination with AVD as frontline therapy for Hodgkin's lymphoma.
Patients classification.
We will categorize patients in three groups as follows:
1. Early stages by Ann-arbor classification (I,II) with no risk factors (as stablished by NCCN's guidelines criteria).
2. Early stages by Ann.arbor classification (I,II) with risk factors ( as stablished by NCCN's guidelines criteria).
3. Advanced stages by Ann-arbor classification (III,IV).
Methodology:
- Patients will receive two initial cycles of NAVD therapy ( each with two applications in day 1 and 15) and then will be evaluated with an interim PET/CT after completing cycle 2.
- According to the PET C/T results, patients will be categorized as fast responsers (patients who achieve Deauville 1-3 classification) and low responsers ( patients who achieve Deauville 4-5).
- Fast responsers will receive following cycles without nivolumab (2 extra cycles for patients categorized as early stage with no risk factors, 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages).
- Patients will receive medical evaluation at first meeting, during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria.
- Adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications.