Vyxeos® and Clofarabine (VyClo)

A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML (ITCC-092)



The clinical study is designed to establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML.

Vyxeos® and Clofarabine are administered intraveneously.

Main inclusion criteria

  • Age ≥ 1 year and < 21 years
  • Any ≥ 2nd relapse of AML
  • Refractory AML (defined as ≥ 20% blasts in the bone marrow after standard induction therapy)
  • Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML
  • Lansky play score ≥ 60 for patients <16 years of age; or Karnofsky performance status ≥ 60 for patients ≥ 16 years of age


Princess Máxima Center for pediatric oncology

 (Utrecht, Netherlands)

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