A Phase 1-2 Study of Bosutinib in Children with Newly Diagnosed PH+ Chronic Myeloid Leukemia in Chronic Phase or with Resistance/Intolerance.

Zusammenfassung der Studie

Patients with chronic myeloid leukemia (CML) are treated with medications called tyrosine kinase inhibitors (TKIs). Imatinib is currently the only TKI approved to treat children with CML. The majority of children with CML respond to imatinib and their disease goes into remission after treatment. However, for some children, the TKIs used so far are no longer suitable. They may have too many side effects or the medications do not work well enough. These children have limited treatment options and are often treated with another TKI, which usually occurs within a clinical trial. In this clinical trial, which is being conducted in Switzerland at the University Children's Hospital in Zurich, we are studying the medication called Bosutinib. Bosutinib is a new class of TKIs that can be taken in pill form. Bosutinib is approved in Switzerland for the treatment of adult patients with CML for whom treatment with other TKIs is no longer effective. This medication is not yet approved for the treatment of CML in children and adolescents. This is the first study in which we will investigate the treatment of children with CML using Bosutinib. We are studying the dosage, safety, and efficacy of Bosutinib. The medication has the potential to become an additional new therapy for children with CML.

(BASEC)

Untersuchte Intervention

We are studying the medication called Bosutinib. The aim of this study is to find a safe and effective dose of Bosutinib for children with CML who have already received treatment with at least one other tyrosine kinase inhibitor. The medication must be taken once a day, preferably in the morning with breakfast. The medication is taken in the form of tablets and/or capsules. We will investigate how children respond to the treatment and what side effects occur as a result of the treatment. The so-called efficacy, safety, and tolerability of the selected Bosutinib dose will be determined. We will also investigate how much Bosutinib enters the bloodstream and how quickly the medication leaves the body. This is called pharmacokinetics (PK). We do this by taking blood samples and determining the blood concentrations of the medication in the laboratory.

(BASEC)

Untersuchte Krankheit(en)

- Chronic myeloid leukemia, resistant to treatment against at least one previous tyrosine kinase inhibitor therapy or intolerant to it. or - newly diagnosed PH+ chronic myeloid leukemia in chronic phase

(BASEC)

Sponsor

Erasmus Medical Center (EMC)

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

20.04.2017

(BASEC)

Ergebnisse der Studie