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RECRUITING
NCT06812858
PHASE2

PD-1 Inhibitors Maintenance for cHL Post-autoHCT

Sponsor: St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

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