Overview

Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia",

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:

Participant gender:

Summary

This is a Phase 1-2, multicenter, international, single-arm, open-label study designed to identify a recommended dose of bosutinib administered orally once daily in pediatric patients with newly diagnosed chronic phase Ph+ CML (ND CML) and pediatric patients with Ph+CML who have received at least one prior TKI therapy (R/I CML), to preliminary estimate the safety and tolerability and efficacy, and to evaluate the PK of bosutinib in this patient population.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Children's Oncology Group

Collaborators:

Dutch Childhood Oncology Group
Dutch Childhood Oncology Group- Early Clinical Trial Consortium
Erasmus MC
Innovative Therapies for Children with Cancer
Pfizer