PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma
NCT07209059 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-10-06
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.
Conditions
- Hodgkin Lymphoma
- Hodgkin Disease
- Advanced Hodgkin Lymphoma
Interventions
- DRUG
-
Monoclonal antibody targeting PD-1; administered in combination regimens
- OTHER
-
N-EACOPD-14
14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.
- OTHER
-
N-AVD
Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).
Sponsors & Collaborators
-
National Research Center for Hematology, Russia
lead NETWORK
Principal Investigators
-
Evgeny E Zvonkov, MD, PhD · National Medical Research Center for Hematology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-29
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- Russia
Study Locations
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