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PET-Adapted Low-Dose Nivolumab With NICE-40 for Relapsed/Refractory Classical Hodgkin Lymphoma
Sponsor: St. Petersburg State Pavlov Medical University
Summary
Nivolumab is an anti-PD-1 antibody with high activity in patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL). A PET-adapted strategy using nivolumab with ICE added for patients without complete response has shown high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, while allowing omission of salvage chemotherapy in a substantial proportion of patients. This study evaluates the safety and efficacy of a PET-adapted strategy using fixed-dose nivolumab 40 mg, with ifosfamide, carboplatin, and etoposide (NICE-40) administered to patients without complete response to nivolumab monotherapy.
Official title: Multicenter 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2021-03-01
Completion Date
2026-09-15
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
Ifosfamide
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
Carboplatin
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
Etoposide
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Locations (5)
St. Petersburg State Pavlov Medical University
Saint Petersburg, Northwestern Federal District, Russia
National Medicine Research Center of oncology named after N.N. Petrov
Saint Petersburg, Pesochny, Russia
Irkutsk Regional Cancer Center
Irkutsk, Russia
Irkutsk State Regional Children's Clinical Hospital
Irkutsk, Russia
Moscow Clinical Research Center Hospital 52 of the Moscow City Health Department
Moscow, Russia