Health Trials

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;

Trial design

Treatments tested in this trial

  • Nivolumab, Pembrolizumab

Treatment groups

83 Participants
are divided into 1 treatment group

Locations

4
Kazakhstan
National Research Oncology Center Astana Kazakhstan
Russia
National Medical and Surgical Center named after N.I. Pirogov Moscow Russia
RecruitingP. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation Moscow Russia
RM Gorbacheva Research Institute, Pavlov University Saint Petersburg Russia

Sponsors and collaborators

St. Petersburg State Pavlov Medical University

Lead sponsor

Source ClinicalTrials.gov