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
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.