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Randomized Controlled Trial
. 2009 Aug;23(8):1410-6.
doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.

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

J E Rubnitz  1 , K R Crews, S Pounds, S Yang, D Campana, V V Gandhi, S C Raimondi, J R Downing, B I Razzouk, C-H Pui, R C Ribeiro
Affiliations
Randomized Controlled Trial

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

J E Rubnitz et al. Leukemia. 2009 Aug.

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/m(2) per dose) and cytarabine either as daily 2-h infusions (500 mg/m(2) per dose) (arm A) or a continuous infusion (500 mg/m(2) 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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Figures

Figure 1
Figure 1. AML97 treatment schema
Patients were randomized to receive cladribine and daily 2-hour infusions (Arm A) or a continuous infusion (Arm B) of cytarabine. The second and third courses of chemotherapy consisted of daunorubicin, cytarabine, and etoposide (DAV). Further therapy was based on risk status and the availability of a matched sibling donor.
Figure 2
Figure 2
Panel A. Event-free survival (EFS) and overall survival (OS) for the 102 patients enrolled in AML97. Panel B. EFS for patients enrolled in Arm A before (Arm A Pre) and after (Arm A Post) treatment amendments, and for patients enrolled in Arm B before (Arm B Pre) and after (Arm B Post) treatment amendments. The curves for Arm B Pre and Arm A Post overlap.
See this image and copyright information in PMC

References

    1. Creutzig U, Zimmermann M, Lehrnbecher T, Graf N, Hermann J, Niemeyer CM, et al. Less toxicity by optimizing chemotherapy, but not by addition of granulocyte colony-stimulating factor in children and adolescents with acute myeloid leukemia: results of AML-BFM 98. J Clin Oncol. 2006;24:4499–4506. - PubMed
    1. Lange BJ, Smith FO, Feusner J, Barnard DR, Dinndorf P, Feig S, et al. Outcomes in CCG-2961, a children’s oncology group phase 3 trial for untreated pediatric acute myeloid leukemia: a report from the children’s oncology group. Blood. 2008;111:1044–1053. - PMC - PubMed
    1. Kaspers GJ, Creutzig U. Pediatric acute myeloid leukemia: international progress and future directions. Leukemia. 2005;19:2025–2029. - PubMed
    1. Carrera CJ, Terai C, Lotz M, Curd JG, Piro LD, Beutler E, et al. Potent toxicity of 2-chlorodeoxyadenosine toward human monocytes in vitro and in vivo. A novel approach to immunosuppressive therapy. J Clin Invest. 1990;86:1480–1488. - PMC - PubMed
    1. Robertson LE, Chubb S, Meyn RE, Story M, Ford R, Hittelman WN, et al. Induction of apoptotic cell death in chronic lymphocytic leukemia by 2- chloro-2′-deoxyadenosine and 9-beta-D-arabinosyl-2-fluoroadenine. Blood. 1993;81:143–150. - PubMed

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