Study design and patients
extranodal lesions, nodular lymphocyte-predominant HL, HL
The randomized phase 3 trial HD16 was conducted at 250 sites in Germany, Switzerland, Austria, and the Netherlands. It was approved by the responsible ethics committees, conducted according to the Declaration of Helsinki and the ICH-GCP guidelines, registered at ClinicalTrials.gov (NCT00736320), and completed enrollment in December 2015 [We recruited patients aged 18–75 years with newly diagnosed, histology-proven classical HL in clinical stages I or II, or nodular lymphocyte-predominant HL in Ann Arbor stages IB, IIA, or IIB, without any of the GHSG risk factors large mediastinal mass (≥a third of the maximal thoracic diameter), extranodal lesions, elevated erythrocyte sedimentation rate (≥50 mm/h without B symptoms, ≥30 mm/h with B symptoms), or ≥3 involved nodal areas. Further details of study design and inclusion/exclusion criteria have been previously published [