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PD-1 Inhibitors Maintenance for cHL Post-autoHCT
Sponsor: St. Petersburg State Pavlov Medical University
Summary
This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
Official title: A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory/Relapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2024-09-02
Completion Date
2030-09
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Nivolumab, Pembrolizumab
The choice of drug and its dose for maintenance therapy is at the discretion of the study centre (e.g. nivolumab, pembrolizumab). Maintenance therapy should be initiated no later than 60 days after D0, exceptions may be made due to reasonable justification in consultation with the Study PI and will not be considered a protocol deviation. Nivolumab maintenance therapy regimens: * Nivolumab (40 mg, fixed dose) IV D1 of each 14-days cycle up to 12 cycles * Nivolumab (3 mg/kg) IV D1 of each 14-days cycle up to 12 cycles Pembrolizumab maintenance therapy regimen: -Pembrolizumab (200 mg, fixed dose) IV D1 of each 21-days cycle up to 8 cycles
Locations (3)
National Research Oncology Center
Astana, Kazakhstan
National Medical and Surgical Center named after N.I. Pirogov
Moscow, Russia
RM Gorbacheva Research Institute, Pavlov University
Saint Petersburg, Russia