NCT07209059RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Research Center for Hematology, Russia
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT07209059
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 29 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or active autoimmune disease requiring systemic therapy
- Vaccination with a live vaccine within 30 days prior to first nivolumab dose
Other illness
- Active hepatitis B or C infection
- Positive test for HIV
- History of non-infectious pneumonitis requiring corticosteroids
- Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)
- Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias
- Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
- Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
- Decompensated diabetes mellitus
- Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation
Lab values
- Severe renal impairment (serum creatinine \> 0.2 mmol/L), unless lymphoma-related
- Cachexia (total serum protein \< 35 g/L), unless due to lymphoma-related liver damage
Other
- Pregnancy or breastfeeding
- Severe hepatic dysfunction, unless directly related to lymphoma
- Sepsis or hemodynamic instability
Who the study is looking for
- 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)
- Age between 18 and 60 years (inclusive)
- ECOG performance status 0-2
- PET-CT performed at baseline
- No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
- Adequate organ function, including:
- Serum creatinine ≤ 0.2 mmol/L
- Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
- Ability to comply with the study protocol and scheduled visits
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Research Center for Hematology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.