RecruitingPhase 2NCT07209059

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

A Single-Center Pilot Study Evaluating the Efficacy and Safety of First-Line Immunochemotherapy With Nivolumab Guided by Interim PET for Stratification and Hazard Minimization in Patients With Advanced Classical Hodgkin Lymphoma (FINISH-HL)


Sponsor

National Research Center for Hematology, Russia

Enrollment

30 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. The FINISH protocol (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) integrates nivolumab into induction therapy and tailors subsequent treatment based on interim PET-CT response. The study also includes exploratory monitoring of circulating tumor DNA (ctDNA) to investigate its role in early response assessment and residual disease detection.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a PET scan-guided treatment approach for people newly diagnosed with advanced Hodgkin lymphoma. Patients start with an immunotherapy drug called Nivolumab, and the treatment is then adjusted based on how well the cancer responds on a PET scan — aiming to reduce chemotherapy exposure while maintaining effectiveness. **You may be eligible if...** - You are 18–60 years old - You have newly diagnosed classical Hodgkin lymphoma at stage IIB (bulky), III, or IV - You have not yet received any chemotherapy, radiation, or immunotherapy for lymphoma - You have at least one tumor measuring 15 mm or more on a CT scan - Your heart, lungs, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have had a prior or currently active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Monoclonal antibody targeting PD-1; administered in combination regimens

OTHERN-EACOPD-14

14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.

OTHERN-AVD

Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).


Locations(1)

National Medical Research Center for Hematology

Moscow, Russia

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NCT07209059


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