Who can enter
- Children with chronic myeloid leukemia in the chronic phase, previously treated with one or more tyrosine kinase inhibitors
- Age: between 1 and 18 years old
Goal
The goal of this study is to study how safe asciminib is in children and adolescents and how well it works.
Background
Chronic myeloid leukemia is a form of bloodcancer. It can be treated with several drugs, one of which is asciminib. Asciminib has until now only been tested in adult patients with CML, and is used in a tablet with 40 mg. We expect children might need smaller tablets. We want to use this study to find the dose needed for children, and to see if that dose needs to change with weight.
Two different tablets are used in this study, firstly the ‘adult’ tablet of 40 mg, but also a mini-tablet of 1 mg. In two different parts both tablets will be tested. A participant will only take 1 type of tablet, either the 40 mg tablet or the 1 mg mini-tablet.
Study details
Official title
A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors
Cancer type
Chronic myeloid leukemia (CML)
Phase
1b/2
Maximum number of patients
30, of whom 1 is expected to participate in the Netherlands
Start date
December 27, 2021
Status
Open
Local principal investigator
Prof. dr. C.M. Zwaan
Sponsor
Novartis Pharma B.V.
Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO and Government of the Netherlands.
Trial registry number
Clinicaltrials.gov: NCT04925479
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 Office.
Last reviewed
May 26, 2023
