VyClo (ITCC-092) (AML)

Recruiting

Who can enter

• Children with acute myeloid leukemia (AML) in whom the disease has returned (relapsed) or responded insufficiently to treatment (refractory)

• Age: 1 up to and including 21 years old

Goal

The goal of this study is to find out how safe the new drug Vyxeos® is, in combination with clofarabine, when given to children and young adults with relapsed/refractory acute myeloid leukemia. This study will establish a safe dosage of Clofarabine in combination with Vyxeos®.

Background

Vyxeos® is a new drug that combines two known drugs (cytarabine and daunorubicin) together in a fixed ratio. This is enclosed in a lipid sphere (liposome), allowing the drugs to access leukemia cells more efficiently.

A study of 309 adults with AML showed that Vyxeos® significantly improved the average duration of survival. Preliminary results from this study are promising. Of the 38 children with relapsed/refractory AML who have received Vyxeos® in study settings to date, approximately 80% respond well to treatment.

In this study, clofarabine is added to treatment with Vyxeos®, with the goal of further improving the efficacy of treatment. Clofarabine is usually administered in combination with other chemotherapy.

In a study in 34 children with relapsed/refractory AML treated with a combination of clofarabine, cytarabine and liposomal daunorubicin, 68% of patients responded to treatment. The side effects were mainly infections. After treatment, 22 patients were able to proceed to stem cell transplantation.

In order to participate in a study please refer to your/your child’s doctor.
For international patients: please feel welcome to contact our International Patients Office.

Last reviewed

March 23, 2026

The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.