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

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 study tests whether PD-1 inhibitors can help prevent relapse in young adults with Hodgkin lymphoma after they’ve had a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: St. Petersburg State Pavlov Medical University (Academic / other)
• Drugs / interventions: brentuximab, pembrolizumab, nivolumab, chemotherapy
• Locations: 4 sites (Astana and 3 other locations)
• Trial ID: NCT06812858 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with relapsed or refractory classical Hodgkin lymphoma who have undergone autologous stem cell transplantation and meet specific high-risk criteria.

Not a fit: Patients who have previously received PD-1 inhibitor therapy or those who do not meet the high-risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve long-term remission rates and overall survival for patients with high-risk classical Hodgkin lymphoma.

How similar studies have performed: Previous studies have shown promising results with PD-1 inhibitors in similar contexts, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Astana and 3 other locations

• 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

Conditions Hodgkin Lymphoma; Classic Hodgkin lymphoma; autologous hematopoietic stem cell transplantation; nivolumab; pembrolizumab