Phase II trial of clofarabine and daunorubicin as induction therapy for acute myeloid leukemia patients greater than or equal to 60 years of age

Leuk Res. 2013 Nov;37(11):1468-71. doi: 10.1016/j.leukres.2013.07.036. Epub 2013 Aug 15.

Abstract

We designed a phase II study evaluating the upfront combination of clofarabine and daunorubicin in acute myeloid leukemia (AML) patients≥60 years old. The median age of the 21 patients was 69 (range 60-85) years. Fourteen patients (67%) had unfavorable risk features. The principal toxicities were grade ≥3 infections and prolonged myelosuppression. Three (14%) deaths occurred from infectious complications. Six (28.6%) patients achieved complete remission including three (21.4%) of 14 patients with unfavorable AML. The median disease-free survival was 6.8 months and the median overall survival was 11.2 months.

Keywords: AML; Clinical trial; Clofarabine; Daunorubicin; Elderly.

Publication types

  • Clinical Trial, Phase II
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine Nucleotides / administration & dosage
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Arabinonucleosides / administration & dosage
  • Clofarabine
  • Daunorubicin / administration & dosage
  • Female
  • Follow-Up Studies
  • Humans
  • Leukemia, Myeloid, Acute / drug therapy*
  • Leukemia, Myeloid, Acute / mortality
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Prognosis
  • Remission Induction
  • Survival Rate

Substances

  • Adenine Nucleotides
  • Arabinonucleosides
  • Clofarabine
  • Daunorubicin