PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Research Center for Hematology, Russia
About this trial
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 criteria
Qualifiers
Signed written informed consent prior to any study-specific procedures
Histologically confirmed classical Hodgkin lymphoma (cHL)
Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
At least one measurable lesion ≥15 mm in the longest diameter (by CT)
Disqualifiers
Active hepatitis B or C infection
Positive test for HIV
Pregnancy or breastfeeding
Prior or active autoimmune disease requiring systemic therapy
Trial design
Treatments tested in this trial
- Nivolumab
- N-EACOPD-14
- N-AVD
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov