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Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
ID07209059

Pilot Study of PET-Guided Nivolumab Immunochemotherapy as First Treatment for Advanced Classical Hodgkin Lymphoma

Led by National Research Center for Hematology, Russia · Updated on 2025-10-06

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new first-line treatment strategy for patients with classical Hodgkin lymphoma cHL who have advanced disease or unfavorable prognostic factors. This phase 2 pilot study, called the FINISH protocol, combines nivolumab with chemotherapy and uses PET-CT scans after two cycles to guide personalized treatment decisions. The study also explores the use of circulating tumor DNA ctDNA to monitor treatment response and detect residual disease early. All participants begin treatment with two cycles of immunochemotherapy combining nivolumab and EACOPD-14. Based on PET-CT results after these cycles, those with a good response receive a less intensive consolidation therapy with nivolumab plus AVD, followed by nivolumab alone. Participants with a poor response continue or intensify therapy, with some potentially withdrawn if their disease remains unresponsive. Blood samples for ctDNA analysis are collected at several points during treatment to assess molecular responses. During the study, patients undergo regular PET-CT scans and blood tests to measure treatment effects and safety. Researchers assess the proportion of patients achieving complete metabolic response at various time points, overall survival, progression-free survival, and treatment side effects. The study aims to improve treatment effectiveness while reducing long-term toxicity by adjusting therapy based on individual responses. Participation lasts through the treatment cycles and includes follow-up for up to 24 months to monitor outcomes and safety.

CONDITIONS

Brief Title

PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma

Research Team

A

Anna A Kravtsova, MD

Y

Yana K Mangasarova, MD

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