Clofarabine in combination with a standard remission induction regimen (cytosine arabinoside and idarubicin) in patients with previously untreated intermediate and bad-risk acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): phase I results of an ongoing phase I/II study

@article{Willemze2014ClofarabineIC,
  title={Clofarabine in combination with a standard remission induction regimen (cytosine arabinoside and idarubicin) in patients with previously untreated intermediate and bad-risk acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): phase I results of an ongoing phase I/II study},
  author={Roel Willemze and Stefan Suciu and Petra Muus and Constantijn J. M. Halkes and Giovanna Meloni and Liv Meert and Matthias Karrasch and J{\'e}r{\^o}me Rapion and Marco Vignetti and S. Amadori and Theo de Witte and Jean Pierre Marie},
  journal={Annals of Hematology},
  year={2014},
  volume={93},
  pages={965-975}
}
This study aims to determine the maximum tolerated dose (MTD) of clofarabine combined with the EORTC-GIMEMA 3 + 10 induction regimen (idarubicin + cytosine arabinoside) in adults with untreated acute myelogenous leukemia or high-risk myelodysplastic syndrome. In this phase I trial, 25 patients (median age 56 years) received 5 days of clofarabine as 1-h infusion (arm A) or push injection (arm B) at the dose level of 5 × 10 or 5 × 15 mg/m2/day in an algorithmic dose escalation 3 + 3 design. A… CONTINUE READING
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