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

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT04258943
Trial Phases:	Phase I Phase II	Protocol IDs:	AAML1921 (primary) NCI-2020-07372 NTR5501 ITCC-054 2015-002916-34
Eligibility:	1 - 17 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Children's Oncology Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT04258943

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.

Objectives

The Phase 1 part of the study employs a 6+4 design (no DLT in 6 patients or 1 DLT in 10
patients) and incorporates additional PK information before escalating to the next dose
level. If there is unacceptable toxicity or if PK results have exceeded the acceptable
exposure levels for the adult equivalent dose, further dose escalation will be
prohibited. The Recommended Phase 2 Dose (RP2D) is defined as the dose that results in
equivalent(approximately ±20% of the adult values) PK exposure to 500 mg/day in adults
and with 0 of 6 or <2 DLTs observed out of 10 evaluable patients with Ph+ CML and
resistance or intolerance to prior TKI therapy. The phase 2 part of the study will enroll
the following patient populations.

- Newly diagnosed (ND): newly diagnosed pediatric Ph + CML patients in chronic phase
(CP)

- Resistant/intolerant (R/I): chronic phase or advanced (accelerated (AP) or blast
phase (BP) pediatric Ph+ CML patients with resistance or intolerance to at least 1
prior TKI

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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