Actively Recruiting
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
Led by St. Petersburg State Pavlov Medical University · Updated on 2026-04-01
178
Participants Needed
3
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
CONDITIONS
Official Title
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients with histologically confirmed stage IIB, III, or IV classical Hodgkin lymphoma who have not received specific therapy
- Evidence of lesion extent assessed by whole-body PET/CT
- Age between 18 and 60 years
- ECOG performance status between 0 and 2
- Use of highly effective contraceptive methods from consent signing through 6 months after last treatment dose
You will not qualify if you...
- Severe organ failure: creatinine above 2 times normal; alanine aminotransferase or aspartate aminotransferase above 5 times normal; bilirubin above 1.5 times normal
- Respiratory failure above grade 1 at enrollment
- Need for vasopressor support at enrollment
- Uncontrolled bacterial or fungal infection at enrollment
- Active or prior autoimmune disease requiring systemic treatment
- Pregnancy, breastfeeding, or planning pregnancy or parenthood during the study
- Allergy or hypersensitivity to study drugs
- Physical or mental conditions preventing study procedures or consent
- Use of other drugs or devices in other clinical trials simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health
Moscow, Russia
Actively Recruiting
2
National Medical and Surgical Center named after N.I. Pirogov
Moscow, Russia
Actively Recruiting
3
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
Actively Recruiting
Research Team
L
Liudmila Fedorova, MD, PhD
CONTACT
P
Polina Kotseliabina, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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