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

RecruitingPhase 2Ages 18 Years - 60 YearsAllSt. Petersburg State Pavlov Medical University
NCT07234487 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Nivo-AVD
  • BEACOPP-like
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Where

3 sites
A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health
Moscow, Russia
National Medical and Surgical Center named after N.I. Pirogov
Moscow, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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