Potential Benefit of Radiotherapy for Patients Undergoing Autologous Stem Cell Transplantation for Relapsed or Refractory Hodgkin's Lymphoma

Objectives, structure and design of the Study

Study design

This will be a retrospective observational study for patients treated with ASCT, comparing those who received peritransplant RT with a subgroup who received a chemotherapy-alone regimen for a relapsed/refractory HL between 2004 and 2014.

Aim of this retrospective study is to investigate for a possible role for RT by comparing patients who received RT (prior or after ASCT) and patients who received salvage chemotherapy (CT) alone.

Primary objective

Overall survival (OS) at 3 and 5 years.

Secondary objectives

  • Progression free survival (PFS) at 3 and 5 years
  • Comparison of late effects between the two cohorts of treatment

Sample size

400 Patients

Number of Centers and location of the Study

20 Centers in Italy

1 Extra-ue center

Study duration

4 years based on the following assumptions:

  1. Recruitment: 12 months
  2. Follow-up: 36 months

Study start date

January 2017