Actively Recruiting
PET-Adapted First-Line Immunochemotherapy With Nivolumab for Advanced Classical Hodgkin Lymphoma (FINISH-HL) Pilot Study
Led by National Research Center for Hematology, Russia · Updated on 2025-10-06
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) who have advanced disease or unfavorable prognostic factors. This phase 2 pilot study, called the FINISH protocol, combines nivolumab with chemotherapy and uses PET-CT scans after two cycles to guide personalized treatment decisions. The study also explores the use of circulating tumor DNA (ctDNA) to monitor treatment response and detect residual disease early. All participants begin treatment with two cycles of immunochemotherapy combining nivolumab and EACOPD-14. Based on PET-CT results after these cycles, those with a good response receive a less intensive consolidation therapy with nivolumab plus AVD, followed by nivolumab alone. Participants with a poor response continue or intensify therapy, with some potentially withdrawn if their disease remains unresponsive. Blood samples for ctDNA analysis are collected at several points during treatment to assess molecular responses. During the study, patients undergo regular PET-CT scans and blood tests to measure treatment effects and safety. Researchers assess the proportion of patients achieving complete metabolic response at various time points, overall survival, progression-free survival, and treatment side effects. The study aims to improve treatment effectiveness while reducing long-term toxicity by adjusting therapy based on individual responses. Participation lasts through the treatment cycles and includes follow-up for up to 24 months to monitor outcomes and safety.
CONDITIONS
Brief Title
PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Histologically confirmed classical Hodgkin lymphoma
- Newly diagnosed Ann Arbor stage IIB (bulky), III, or IV disease
- At least one measurable lesion 15 mm or larger by CT scan
- Age between 18 and 60 years inclusive
- ECOG performance status between 0 and 2
- PET-CT scan performed at baseline
- No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
- Adequate organ function including serum creatinine ≤ 0.2 mmol/L
- No severe cardiac, pulmonary, hepatic, or renal dysfunction
- Ability to follow study protocol and attend scheduled visits
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
- Live vaccine received within 30 days before first nivolumab dose
- History of non-infectious pneumonitis requiring corticosteroids
- Prior malignancy except treated basal cell carcinoma or cervical carcinoma in situ
- Congestive heart failure, unstable angina, recent heart attack, or severe arrhythmias
- Severe renal impairment unless related to lymphoma
- Severe liver dysfunction unless related to lymphoma
- Severe pneumonia with respiratory failure not corrected within 2-3 days
- Sepsis or hemodynamic instability
- Life-threatening bleeding events such as gastrointestinal or brain hemorrhage
- Cachexia with low total serum protein unless from lymphoma-related liver damage
- Decompensated diabetes mellitus
- Any somatic or psychiatric condition preventing informed consent or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 to 14 weeks
Participants receive initial immunochemotherapy with nivolumab plus EACOPD-14 for 2 cycles. After an interim PET-CT scan, treatment is adapted based on response: those with a complete metabolic response receive de-escalated consolidation therapy with Nivolumab plus AVD for 2 cycles followed by nivolumab monotherapy for 2 cycles; those with inadequate response continue or intensify therapy based on further PET results.
Treatment cycles with PET scans after 2, 4, and 6 cycles; ctDNA samples collected at baseline and after 2, 4, and 6 cycles
Duration - Up to 24 months
Participants are monitored for safety and long-term outcomes including survival and metabolic response for up to 24 months after treatment completion.
Regular visits as scheduled for safety and outcome monitoring
Trial Site Locations
Total: 1 location
1
National Medical Research Center for Hematology
Moscow, Russia, 125167
Actively Recruiting
Research Team
A
Anna A Kravtsova, MD
Y
Yana K Mangasarova, MD
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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