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Acute Leukemias

Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial

Abstract

Because cladribine can increase cytarabine triphosphate levels, we tested a cladribine–cytarabine combination in the St Jude AML97, trial in which this combination was administered before standard chemotherapy to 96 children with acute myeloid leukemia (AML) or myelodysplastic syndrome. Patients received a 5-day course of cladribine (9 mg/m2 per dose) and cytarabine either as daily 2-h infusions (500 mg/m2 per dose) (arm A) or a continuous infusion (500 mg/m2 per day) (arm B). Ara-CTP levels and inhibition of DNA synthesis increased from day 1 to day 2, but were not different between the two arms. In addition, the median blast percentages at day 15 did not differ between arms A and B, but patients treated in arm A had shorter intervals between the initiation of the first and second courses of therapy. Thus, although there were trends toward better complete remission rates and overall survival for patients treated in arm B, the reduced efficacy of arm A may have been partially compensated by more intense timing of therapy for that group. For all patients, 5-year event-free survival and overall survival estimates were 44.1±5.4 and 50.0±5.5%. Our results suggest that cladribine in combination with continuous-infusion cytarabine is effective therapy for childhood AML.

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Acknowledgements

We thank Vani Shanker for expert editorial review. This work was supported in part by Cancer Center Support (CORE) grant P30 CA-21765 from the National Institutes of Health, by a Center of Excellence Grant from the State of Tennessee and by the American Lebanese Syrian Associated Charities (ALSAC). C-H Pui is an American Cancer Society professor.

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Correspondence to J E Rubnitz.

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Rubnitz, J., Crews, K., Pounds, S. et al. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia 23, 1410–1416 (2009). https://doi.org/10.1038/leu.2009.30

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