💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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
Exclusion Criteria:
* Active hepatitis B or C infection
* Positive test for HIV
* Pregnancy or breastfeeding
* Prior or active autoimmune disease requiring systemic therapy
* Vaccination with a live vaccine within 30 days prior to first nivolumab dose
* 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 renal impairment (serum creatinine \> 0.2 mmol/L), unless lymphoma-related
* Severe hepatic dysfunction, unless directly related to lymphoma
* Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
* Sepsis or hemodynamic instability
* Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
* Cachexia (total serum protein \< 35 g/L), unless due to lymphoma-related liver damage
* Decompensated diabetes mellitus
* Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation
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