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

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

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

Conditions4

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