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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSt. Petersburg State Pavlov Medical University

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nivo-AVD
  • BEACOPP-like

Treatment groups

178 Participants
are divided into 2 treatment groups