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

Trial ID or NCT#

NCT04258943

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase I/II Study of Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia", Study ITCC-054/COG-AAML1921

Eligibility Criteria

Ages Eligible for Study: 1 Year to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Jay Michael S. Balagtas

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Contact

Stefania Ursu Chirita
650-723-1423