About the study

N-BURGUND is a clinical trial evaluating the efficacy of nivolumab administered before salvage BGD chemotherapy and autologous haematopoietic stem cell transplantation in patients with classical Hodgkin lymphoma that is refractory to first-line treatment or has relapsed.

The aim of the project is to improve treatment outcomes in this patient population through the early introduction of immunotherapy before standard salvage chemotherapy.

The study hypothesis assumes that nivolumab may increase response rates to BGD treatment and reduce the risk of relapse following autologous stem cell transplantation.

What is Hodgkin lymphoma?

Hodgkin lymphoma is a cancer of the lymphatic system. It is classified into classical Hodgkin lymphoma and a rarer non-classical form.

Only patients with histopathologically confirmed classical Hodgkin lymphoma are eligible for participation in the N-BURGUND study.

The project focuses on patients with relapsed disease or primary resistance to first-line treatment, a group in which standard treatment outcomes remain unsatisfactory.

Why is this study important?

In some patients with classical Hodgkin lymphoma, first-line treatment does not provide durable disease control. In such cases, salvage treatment and consideration of autologous stem cell transplantation are required.

The N-BURGUND study aims to determine whether earlier administration of nivolumab before second-line chemotherapy can improve the effectiveness of the entire treatment pathway.

According to the study assumptions, this may increase the rate of long-term remission and reduce the need for more intensive therapies at later stages of treatment.

Why nivolumab?

Nivolumab works differently from conventional chemotherapy. It activates the patient’s T lymphocytes and enhances the immune system’s response against cancer cells.

The medicine is already used in the treatment of Hodgkin lymphoma and several other cancers and has a well-established safety profile.

The N-BURGUND study evaluates its earlier use, before standard BGD salvage chemotherapy.

Study design

N-BURGUND is a phase II clinical trial.

The treatment strategy consists of a sequential approach: 3 cycles of nivolumab, followed by 2 cycles of BGD chemotherapy, and then autologous haematopoietic stem cell transplantation (aHSCT).

An additional objective of the project is to evaluate the predictive value of circulating tumour DNA (ctDNA) in relation to progression-free survival.

Who can participate?

The study is intended for adult patients with relapsed histopathologically confirmed classical Hodgkin lymphoma, including patients with primary resistance to first-line treatment.

• 18 years of age or older;
• classical Hodgkin lymphoma;
• relapsed disease or primary resistance to first-line treatment;
• at least one measurable lesion.

A positive PET result after the second cycle of first-line chemotherapy may also fulfil the criterion of primary treatment resistance.

Project timeline

• study registration and regulatory approvals: 29 March 2021 – 29 March 2022;
• patient recruitment and study conduct: 01 March 2022 – 01 March 2025;
• patient follow-up: 02 December 2024 – 29 March 2027;
• data analysis and final report: 01 September 2026 – 29 March 2027.

Research team

The scientific and medical coordinator of the project is Jan Maciej Zaucha, MD, PhD, Professor.

The study is supported by an operational, monitoring and project management team, including a medical monitor, clinical operations manager, pharmacist, pharmacovigilance specialists, statisticians, a data manager, a financial project coordinator and a quality assurance specialist.

Organisational information

The project is funded through the Medical Research Agency (MRA) under the funding call for research and development activities in non-commercial clinical trials ABM/2020/1.

Project number: 2020/ABM/01/00103.

Project duration: 29 March 2021 – 29 March 2027.