Objective Acute lymphoblastic leukaemia (ALL) in infants is a rare entity, biologically distinctive and associated with a poor prognosis. Optimal therapy remains controversial. Our objective was to characterise infants treated for newly diagnosed ALL in our centre.

Methods Retrospective study of patients younger than one year admitted with ALL from January 2000 to December 2007. Available demographic, clinical and laboratory (including molecular study) data were analysed.

Results Seven infants were studied (one female). The mean age at diagnosis was 8.2 ± 3.3 months (range 2.3–11.3). One case had T-cell ALL; another had acute mixed lineage leukaemia; the remainder had B-cell ALL. Initial leucocyte counts ranged from 5900 to 127 000/mm³ (median 60 800/mm³). Five patients (71.4%) had leucocyte counts greater than 50 000/mm³. Two patients had central nervous system (CNS) involvement at diagnosis. Two patients were CD10 positive and one had t(4;11) with MLL rearrangement. The patient with mixed lineage leukaemia underwent AML-BFM98 protocol and the others followed DFCI 91-01. Two infants underwent unrelated cord blood transplantation in the first complete remission. Two patients relapsed (testicular and CNS sites). Two patients died: one without achieving complete remission after 2 months of chemotherapy, the other 2 months after diagnosis. Long-term side effects in survivors were mainly cognitive. Disease-free survival rate was 0.43 ± 0.19 (mean follow-up 21 months) and overall survival was 0.71 ± 0.17.

Conclusions The few patients presented reinforce the need for multicentre collaborative studies. Our results concerning disease-free survival were similar to those reported in the literature. Overall survival is good, probably related to the median age being higher than other cases reported.