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

Summary

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

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

Conditions2

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