Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL

Recruiting now · Phase 2

Conditions studied: Hodgkin Lymphoma

In brief

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

Key facts

Study ID

NCT07234487

Run by

St. Petersburg State Pavlov Medical University

People needed

178

Starts

2024-10-14

Expected to finish

2030-10-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
• Respiratory failure > grade 1 at the time of enrollment
• Requirement for vasopressor support at the time of enrollment
• Uncontrolled bacterial or fungal infection at the time of enrollment
• Active or prior documented autoimmune disease requiring systemic treatment
• Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
• Hypersensitivity or allergy to study drugs
• Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
• Simultaneous use of drugs or medical devices studied in other clinical trials

Where it is running

• A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health — Moscow, Russia (enrolling)
• National Medical and Surgical Center named after N.I. Pirogov — Moscow, Russia (enrolling)
• St. Petersburg State Pavlov Medical University — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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