PD-1 Inhibitors Maintenance for cHL Post-autoHCT

ConditionHodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorSt. Petersburg State Pavlov Medical University

About this trial

This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)

Eligibility criteria

Qualifiers

18-70 years;

Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;

High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed)

Complete or partial response by PET/CT after auto-HSCT

Disqualifiers

Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;

Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;

Respiratory failure of more than 1 degree at the time of inclusion in the study;

Unstable haemodynamics at the time of inclusion in the study;