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)
Recruiting
Summary
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
Sponsor
| Princess Máxima Center for pediatric oncology |
(Utrecht, Netherlands)