Nivolumab with AVD versus PET-adapted BEACOPP-like for advanced classical Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective multicenter phase II randomized trial enrolls adults with newly diagnosed stage IIB–IV classical Hodgkin lymphoma and randomizes them to one of two first-line strategies. In the experimental arm patients receive two cycles of nivolumab alone followed by nivolumab plus AVD for a total of six cycles. In the standard arm patients start with two cycles of BEACOPP-like chemotherapy and are then managed per PET response after two cycles, either switching to A(B)VD or continuing BEACOPP-like therapy. Whole-body PET/CT is used for staging and on-treatment response assessment, and the study compares disease control and toxicity between the approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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's running

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

Study contacts

• Study coordinator: Liudmila Fedorova, MD, PhD
• Email: md.FedorovaL@gmail.com
• Phone: +78123386265

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.