The BCHILD study: Bosutinib in pediatric CML
Research type
Research Study
Full title
A phase I/II study of bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy, ITCC-054/AAML1621
IRAS ID
215159
Contact name
Donna Lancaster
Contact email
Sponsor organisation
Erasmus MC
Eudract number
2015-002916-34
Clinicaltrials.gov Identifier
NTR, NTR5501
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
Bosutinib has demonstrated activity in the treatment of adult patients with CML and is approved for the treatment of adult CML patients with resistance or intolerance to Tyrosine kinase inhibitor (TKIs) in US and EU. Bosutinib has been shown to have a tolerable and manageable safety profile in adult CML patients, including the subpopulations of patients with unmet medical need.
However, no pharmacokinetic, safety or efficacy data exist with bosutinib in pediatric patients. Given that new agents are needed to address Tyrosine kinase inhibitor (TKI) resistance and intolerance in pediatric CML, bosutinib will be studied in this Phase 1 study in children and adolescents with all phases of CML who are resistant or intolerant to TKI therapy.
This Phase 1 study will be initiated to identify a safe and tolerable dose of bosutinib in pediatric patients and will begin to characterize the toxicity profile, anti-leukemia effect, and short- and long-term safety and tolerability of bosutinib in this population.
Treatment of children and adolescents with bosutinib may result in improvement of their disease state.REC name
London - Central Research Ethics Committee
REC reference
18/LO/0667
Date of REC Opinion
8 May 2018
REC opinion
Favourable Opinion