Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.

Inclusion Criteria:Diagnosis: Histologically confirmed Hodgkins lymphomaRelapsed or refractory disease after the first line of treatmentAge 18-70 years oldEjection fraction greater than 50%ECOG 0-2 statusSigned informed consentNo severe concurrent illnessExclusion Criteria:Uncontrolled bacterial or fungal infection at the time of enrollmentRequirement for vasopressor support at the time of enrollmentSevere organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normsKarnofsky index <30%PregnancySomatic or psychiatric disorder making the patient unable to sign an informed consentActive or prior documented autoimmune disease requiring systemic treatment.