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Recruiting Phase 2

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

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About this study

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.

Condition
Hodgkin Lymphoma, Hodgkin Disease, Advanced Hodgkin Lymphoma
Tested
Nivolumab, N-EACOPD-14, N-AVD
Sponsor
National Research Center for Hematology, Russia

Who can join

Age
18 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 60 years
  • Study condition: Hodgkin Lymphoma, Hodgkin Disease, Advanced Hodgkin Lymphoma
  • 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 16

  • 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

Where

1 site, 1 recruiting

National Medical Research Center for Hematology

Moscow, Russia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.