Lowdose Nivolumab in Combination With AVD as Front Line Therapy for Classic Hodgkin's Lymphoma
16 patients around the world
Available in Mexico
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.