Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
NCT07209059

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

Led by National Research Center for Hematology, Russia · Updated on 2025-10-06

30

Participants Needed

1

Research Sites

174 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 35 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 34 0.2 mmol/L
  • Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
  • Ability to comply with the study protocol and scheduled visits
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Medical Research Center for Hematology

Moscow, Russia, 125167

Actively Recruiting

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Research Team

A

Anna A Kravtsova, MD

CONTACT

Y

Yana K Mangasarova, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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