Volume 15, Issue 8, Pages 809-818 (July 2014) Augmented post-remission therapy for a minimal residual disease-defined high-risk subgroup of children and young people with clinical standard-risk and intermediate-risk acute lymphoblastic leukaemia (UKALL 2003): a randomised controlled trial  Prof Ajay Vora, FRCPath, Nick Goulden, PhD, Chris Mitchell, FRCPCH, Jeremy Hancock, PhD, Rachael Hough, MD, Clare Rowntree, PhD, Prof Anthony V Moorman, PhD, Rachel Wade, MSc  The Lancet Oncology  Volume 15, Issue 8, Pages 809-818 (July 2014) DOI: 10.1016/S1470-2045(14)70243-8 Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 1 Outline of treatment regimens for clinical risk groups IM=interim maintenance. DI=delayed intensification. BFM=Berlin-Frankfurt-Munster. MRD=minimal residual disease. MRD high-risk patients assigned to augmented therapy transferred to regimen C after induction. The Lancet Oncology 2014 15, 809-818DOI: (10.1016/S1470-2045(14)70243-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 2 Trial profile MRD=minimal residual disease. SER=slow early response. *One patient had Burkitt's lymphoma, one T-cell lymphoma, one T-cell non-Hodgkin lymphoma, one mature B-cell acute lymphoblastic leukaemia, two acute myeloid leukaemia, five mixed-phenotype acute leukaemia, and one precursor B non-Hodgkin lymphoma. †52 patients were transferred to EsPhALL and seven to another Philadelphia chromosome-positive study protocol. ‡No high-risk randomised patients were lost to follow-up within 1 year or excluded from analysis. The Lancet Oncology 2014 15, 809-818DOI: (10.1016/S1470-2045(14)70243-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 3 Event-free survival (A) and relapse risk (B) by randomly allocated treatment group 44 event-free survival events occurred in the standard group vs 28 in the augmented group. 35 patients in the standard group had a relapse vs 20 in the augmented group. Numbers at risk apply to both graphs. The Lancet Oncology 2014 15, 809-818DOI: (10.1016/S1470-2045(14)70243-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 4 Subgroup analyses for event-free survival O–E=observed events minus expected events. OR=odds ratio. NCI=National Cancer Institute. MRD=minimal residual disease. BCP-ALL=B-cell precursor acute lymphoblastic leukaemia. *95% CI for overall results. †Smaller numbers of patients were included in the overall adjusted analysis because the MRD level on day 29 was unknown in six patients and the cytogenetic risk group was unknown in 32 patients. Cytogenetic risk group was analysed as two groups: BCP-ALL good and BCP-ALL intermediate/poor. χ21=1 degree of freedom in χ2 test. The Lancet Oncology 2014 15, 809-818DOI: (10.1016/S1470-2045(14)70243-8) Copyright © 2014 Elsevier Ltd Terms and Conditions