About the study

RAFTING is a prospective, multicentre, international phase II clinical trial evaluating personalised treatment strategies for patients with early-stage Hodgkin lymphoma.

The project is based on a risk-adapted approach that incorporates both baseline disease characteristics and early treatment response assessed by PET imaging after two cycles of chemotherapy.

The primary objective of the study is to determine whether radiotherapy can be safely omitted in selected low-risk patients without compromising treatment outcomes.

What is Hodgkin lymphoma?

Hodgkin lymphoma is a cancer of the lymphatic system that most commonly develops in the lymph nodes. It generally responds well to treatment, particularly in the early stages of the disease.

Standard treatment usually includes chemotherapy and, in many cases, consolidative radiotherapy.

Although this approach is highly effective, radiotherapy may be associated with long-term adverse effects. For this reason, researchers continue to explore opportunities for further treatment individualisation.

Why is this study important?

The aim of the project is to provide treatment that is more precisely tailored to each patient’s individual risk profile.

Patients classified as low risk are treated with chemotherapy alone, without consolidative radiotherapy, which remains part of the current standard of care.

High-risk patients receive standard treatment supplemented with nivolumab immunotherapy.

The study seeks to determine whether omission of radiotherapy in selected patients can reduce long-term treatment-related complications without increasing the risk of relapse.

What is the RAFTING treatment strategy?

The project uses baseline metabolic tumour volume (MTV) assessment together with interim PET results obtained after two cycles of ABVD chemotherapy.

Patients with a favourable risk profile may be treated with chemotherapy alone, without radiotherapy.

Patients at higher risk receive intensified treatment that includes chemotherapy, radiotherapy and nivolumab immunotherapy.

An additional objective of the study is to evaluate the prognostic value of circulating tumour DNA (cfDNA) in predicting relapse among low-risk patients.

Clinical significance of the project

According to the study assumptions, approximately 60% of patients may avoid radiotherapy, resulting in a shorter treatment duration and a lower risk of long-term complications.

Reducing treatment intensity to the minimum necessary while maintaining efficacy may benefit both patients and healthcare systems.

The primary endpoint of the project is the evaluation of 3-year progression-free survival (3-year PFS) in low-risk patients with early-stage Hodgkin lymphoma treated with chemotherapy alone.

Study population

The study enrolled previously untreated patients diagnosed with classical Hodgkin lymphoma, stage IA or IIA.

Eligibility required the absence of bulky disease, defined as lesions measuring more than 10 cm in diameter.

The project therefore focuses on patients with early-stage, non-bulky disease and a favourable or intermediate-risk profile.

Participating centres

RAFTING is an international study conducted in centres across Poland, Switzerland, Italy and Spain.

In Poland, the project involves specialised haematology and haemato-oncology centres.

Research team

The national principal investigator is Jan Maciej Zaucha, MD, PhD, Professor, Head of the Department and Clinic of Haematology and Transplantology at the Medical University of Gdańsk.

The international principal investigator is Andrea Gallamini, MD, Professor from Centre Antoine Lacassagne in Nice.

The project is supported by a multidisciplinary operational and monitoring team, including a medical monitor, start-up specialists, pharmacists, pharmacovigilance specialists, statisticians and quality assurance experts.

Organisational information

The project is funded by the Medical Research Agency (MRA) under the non-commercial clinical trials funding call ABM/2019/1.

Project number: 2019/ABM/01/00060.

Funding and total project value: PLN 19,859,259.16.

Project duration: 03 July 2020 – 02 July 2026.