This trial explored the efficacy of re-induction chemotherapy including bortezomib in paediatric relapsed/refractory acute lymphoblastic leukaemia. Patients were randomized 1:1 to bortezomib (1.3 mg/m2/dose) administered early or late to a dexamethasone and vincristine backbone. Both groups did not differ regarding peripheral blast count on day 8, the primary endpoint. After cycle 1, 8 of 25 (32%) patients achieved complete remission with incomplete blood count recovery, 7 (28%) a partial remission and 10 had treatment failure. Most common grade 3–4 toxicities were febrile neutropenia (31%) and pain (17%). Bortezomib was safely combined with vincristine. Bortezomib rarely penetrated the cerebrospinal fluid.

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Keywords acute leukaemia, bortezomib, childhood leukaemia, pharmacokinetics, proteasome inhibitor
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Journal British Journal of Haematology
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Kaspers, G.J, Niewerth, D. (Denise), Wilhelm, B.A.J. (Bram A. J.), Scholte-van Houtem, P. (Peggy), Lopez-Yurda, M. (Marta), Berkhof, J, … Zwaan, C.M. (2018). An effective modestly intensive re-induction regimen with bortezomib in relapsed or refractory paediatric acute lymphoblastic leukaemia. British Journal of Haematology, 181(4), 523–527. doi:10.1111/bjh.15233