RECRUITINGPhase 2INTERVENTIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed written willing to sign a consent form prior to any study-specific procedures - diagnosed by tissue sample (biopsy-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) - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 - PET-CT performed at baseline - No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma - your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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 Who Should NOT Join This Trial: - Active hepatitis B or C infection - Positive test for HIV - Pregnancy or breastfeeding - Prior or active autoimmune conditions (where your immune system attacks your own body) 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Nivolumab

Monoclonal antibody targeting PD-1; administered in combination regimens

OTHER

N-EACOPD-14

14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.

OTHER

N-AVD

Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).

Locations (1)

National Medical Research Center for Hematology

Moscow, Russia