A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Sex: All

Ages: 18 Years – 70 Years

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 30

Sponsor: St. Petersburg State Pavlov Medical University

Location: National Medicine Research Center of oncology named after N.N. Petrov Saint Petersburg Pesochny

Summary

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first 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 fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.

Eligibility Criteria

Inclusion Criteria: * Diagnosis: Histologically confirmed Hodgkins lymphoma * Relapsed or refractory disease after the first line of treatment * Age 18-70 years old * Ejection fraction greater than 50% * ECOG 0-2 status * Signed informed consent * No severe concurrent illness Exclusion Criteria: * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms * Karnofsky index \

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Source: ClinicalTrials.gov (NCT04981899). StuddyBuddy aggregates publicly available trial information.