NCT07234487RecruitingPhase 2
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- Oct 2024
- Primary completion date
- Oct 2029
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT07234487
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 178
- From Oct 2024 to the primary completion date, Oct 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune disease requiring systemic treatment
- Simultaneous use of drugs or medical devices studied in other clinical trials
Other illness
- Respiratory failure \> grade 1 at the time of enrollment
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Hypersensitivity or allergy to study drugs
Lab values
- Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
Other
- Requirement for vasopressor support at the time of enrollment
- Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
- Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
Who the study is looking for
- Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;
- Patients with evidence of lesion extent assessed by whole-body PET/CT;
- Patients aged 18-60 years;
- ECOG 0-2;
- Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| National Medical and Surgical Center named after N.I. Pirogov Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| St. Petersburg State Pavlov Medical University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.