A phase I/II randomized trial of clofarabine or fludarabine added to idarubicin and cytarabine for adults with relapsed or refractory acute myeloid leukemia. Issue 4 (3rd April 2018)

• Record Type: Journal Article
• Authors: Short, Nicholas J.; Kantarjian, Hagop; Ravandi, Farhad; Huang, Xuelin; Xiao, Lianchun; Garcia-Manero, Guillermo; Plunkett, William; Gandhi, Varsha; Sasaki, Koji; Pemmaraju, Naveen; Daver, Naval G.; Borthakur, Gautam; Jain, Nitin; Konopleva, Marina; Estrov, Zeev; Kadia, Tapan M.; Wierda, William G.; DiNardo, Courtney D.; Brandt, Mark; O'Brien, Susan M.; Cortes, Jorge E.; Jabbour, Elias
• Is Part Of: Leukemia & lymphoma. Volume 59:Issue 4(2018)
• Page Start: 813
• Page End: 820
• Publication Date: 2018-04-03
• Subjects: Acute myeloid leukemia -- relapsed -- refractory -- purine nucleoside analogues -- clofarabine -- fludarabine; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2017.1349907
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: The purine nucleoside analogues clofarabine and fludarabine are active in acute myeloid leukemia (AML). We conducted a phase I/II randomized study of idarubicin and cytarabine with either clofarabine (CIA) or fludarabine (FIA) for relapsed or refractory AML. Clofarabine 15 mg/m 2 was identified as the recommended phase II dose. Eighty-one patients were assigned using adaptive randomization to CIA ( n = 48) or FIA ( n = 33). The complete response (CR)/CR without platelet recovery rate did not differ between CIA and FIA (38% versus 30%, respectively; p = .50). In both arms, more than half of patients who had received only one prior line of therapy achieved remission. The median event-free survival for CIA and FIA was 2.0 and 1.9 months ( p = .48), and the median overall survival was 6.3 and 4.7 months, respectively ( p = .28). No significant differences in adverse events or early mortality rates were observed. Overall, CIA and FIA resulted in similar response rates and survival in patients with relapsed/refractory AML.