Multicenter randomized phase 2 trial of BendaEAM versus BEAM as autoSCT conditioning regimen for relapsed lymphoma

Replacement of carmustine (BCNU) in the BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) with bendamustine (BendaEAM) before autologous stem cell transplantation (autoSCT) is feasible in lymphoma. Randomized trials have been lacking. The randomized phase 2 BEB trial, at four centers in Austria and Switzerland, compared BendaEAM versus BEAM as autoSCT conditioning regimen in patients with relapsed lymphoma. All patients engrafted rapidly. Lung toxicity (primary end point) did not differ between both groups. Acute toxicities of grade 3 or higher were comparable between the groups. Overall and progression-free survival and complete remission after one year were similar, and no difference in quality of life was observed. The authors conclude that results were similar for both regimens in terms of survival and response rates. A phse 3 non-inferiority study is required to investigate whether BendaEAM can be considered as an alternative to BEAM.