A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML

Trial Profile

A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Sep 2016

At a glance

  • Drugs Clofarabine (Primary) ; Cytarabine; Cytarabine; Daunorubicin liposomal
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Acronyms CLARA-DNX
  • Most Recent Events

    • 23 Dec 2015 Status changed from recruiting to completed, as reported by Netherlands Trial Register.
    • 29 Jul 2014 In phase 1b, 2 patients had dose-limiting toxicities at dose level 3 which required suspension of dose-escalation. Hence, the protocol was amended requiring screening of the patients with computer tomography and serum-galactomannan prior to enrollment.
    • 10 Dec 2013 Interim results presented at the 55th Annual Meeting and Exposition of the American Society of Hematology.
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