Using PD-1 inhibitors to prevent relapse in Hodgkin lymphoma after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the effectiveness of PD-1 inhibitors, specifically nivolumab and pembrolizumab, as maintenance therapy for patients with relapsed or refractory classical Hodgkin lymphoma (cHL) following autologous hematopoietic stem cell transplantation (auto-HCT). The study aims to improve long-term remission rates in patients who have undergone auto-HCT but are at high risk of relapse. By administering these inhibitors post-transplant, the researchers hope to prevent disease progression and enhance progression-free survival. The study includes patients aged 18-70 with specific high-risk criteria and requires a complete or partial response after auto-HCT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

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

Study contacts

• Study coordinator: Polina Kotseliabina, MD
• Email: md.FedorovaL@gmail.com
• Phone: +78123386265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.