PD-1 Inhibitors Maintenance for cHL Post-autoHCT

Recruiting now · Phase 2

Conditions studied: Hodgkin Lymphoma

In brief

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)

Key facts

Study ID

NCT06812858

Run by

St. Petersburg State Pavlov Medical University

People needed

83

Starts

2024-01-09

Expected to finish

2030-09-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
• Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count> 1 109/L, absolute neutrophil count> 0.5 109/L, platelets > 25 109/L);
• ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI

You may not qualify if…

• 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;
• Acute bacterial, viral or fungal infection at the time of inclusion;
• Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible);
• Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;
• Somatic or psychiatric pathology that prevents the signing of informed consent;

Where it is running

• National Research Oncology Center — Astana, Kazakhstan (enrolling)
• National Medical and Surgical Center named after N.I. Pirogov — Moscow, Russia (enrolling)
• 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 (enrolling)
• RM Gorbacheva Research Institute, Pavlov University — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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