AALL1231: bortezomib in newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoma, with cranial radiotherapy removed

Children's Oncology Group phase 3 trial: 824 eligible children and young adults with T-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma enrolled between 2014 and 2017 were randomised to a modified augmented BFM regimen with or without bortezomib during induction and delayed intensification; the backbone was intensified so that prophylactic cranial radiotherapy was scheduled for only 9.5 percent of patients.

Four-year event-free survival was 80.1 percent without and 83.8 percent with bortezomib (p 0.131); overall survival 85.7 and 88.3 percent (p 0.085). Patients with lymphoblastic lymphoma had significantly better event-free (86.4 against 76.5 percent) and overall survival (89.5 against 78.3 percent) with bortezomib. Patients spared cranial radiotherapy did as well as comparable irradiated patients in the predecessor trial AALL0434.