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Increased remissions from one course for intermediate-dose cytosine arabinoside and idarubicin in elderly acute myeloid leukaemia when combined with cladribine. A randomized population-based phase II study

  • Gunnar Juliusson
  • M Hoglund
  • K Karlsson
  • C Lofgren
  • L Mollgard
  • C Paul
  • U Tidefelt
  • M Bjorkholm
Publiceringsår: 2003
Språk: Engelska
Sidor: 810-818
Publikation/Tidskrift/Serie: British Journal of Haematology
Volym: 123
Nummer: 5
Dokumenttyp: Artikel i tidskrift
Förlag: Federation of European Neuroscience Societies and Blackwell Publishing Ltd


Cladribine has single-drug activity in acute myeloid leukaemia (AML), and may enhance the formation of the active metabolite (ara-CTP) of cytosine arabinoside (ara-C). To evaluate the feasibility of adding intermittent cladribine to intermediate-dose ara-C (1 g/m(2)/2 h) b.i.d. for 4 d with idarubicin (CCI), we performed a 2:1 randomized phase II trial in AML patients aged over 60 years. Primary endpoints were time to recovery from cytopenia and need for supportive care following the first course. Sixty-three patients (median 71 years, range 60-84 years) were included, constituting 72% of all eligible patients. Toxicity was limited, with no differences between the treatment arms. The early toxic death rate was 11%. The median time to recovery from neutropenia and thrombocytopenia was 22 and 17 d from the start of course no. 1, respectively, and the requirement for platelet and red cell transfusions was four and eight units respectively. Patients had a median of 8 d with fever over 38degreesC, and 17 d with intravenous antibiotic treatment. The overall complete remission (CR) rate was 62%, with 51% CR from one course of CCI in comparison with 35% for the two-drug therapy (P = 0.014). The median survival with a 2-year follow-up was 14 months, and the 2-year survival was over 30%, with no differences between the treatment arms. Considering the median age and our population-based approach, the overall results are encouraging.


  • Hematology
  • survival
  • toxicity
  • cladribine
  • AML
  • elderly


  • ISSN: 0007-1048

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