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Summary No data on inotuzumab ozogamicin (InO) in infant acute lymphoblastic leukaemia (ALL) have been published to date. We collected data internationally on infants/young children (<3 years) with ALL treated with InO. Fifteen patients (median 4.4 months at diagnosis) received InO due to relapsed or refractory (R/R) disease. Median percentage of CD22+ blasts was 72% (range 40–100%, n = 9). The median dose in the first course was 1.74 mg/m2 (fractionated). Seven patients (47%) achieved complete remission; one additional minimal residual disease (MRD)‐positive patient became MRD‐negative. Six‐month overall survival was 47% (95% confidence interval [CI] 27–80%). Two patients developed veno‐occlusive disease after transplant. Further evaluation of InO in this subgroup of ALL is justified.

ConclusionHaplo-HSCT in 1 and 2 remissions of AL allows to achieve 10-year OS in 64.7% of children, while the type of acute leukemia does not influence the outcome of haplo-HSCT. The acceptable frequency of development of aGVHD III 0 -IV 0 -18.6% allows to treat haplo-HSCT as therapy in 1 and 2 remissions of high risk group. The main complication of haplo-HSCT is relapse -23.5% in the early posttransplant period to D + 100.

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