Tests PD-1 drugs as maintenance after stem cell transplant for Hodgkin lymphoma
Tests nivolumab or pembrolizumab after stem cell transplant in adults with returning Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: PD-1 Inhibitors Maintenance for cHL Post-autoHCT
Key facts
- Where
- Moscow and Saint Petersburg, RussiaSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06812858, who can take part
Where in Russia
- National Medical and Surgical Center named after N.I. PirogovMoscow, RussiaTaking people
- 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 FederationMoscow, RussiaTaking people
- RM Gorbacheva Research Institute, Pavlov UniversitySaint Petersburg, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Petersburg State Pavlov Medical University
- Trial code
- NCT06812858
- Record updated
- 22 May 2026
- Original description
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)Read full original descriptionShow less
A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory/Relapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
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)
Inclusion: 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.
Exclusion: 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; Respiratory failure of more than 1 degree 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); Somatic or psychiatric pathology that prevents the signing of informed consent; Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN; Unstable haemodynamics at the time of inclusion in the study; Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period.