Chronic Myeloid Leukemia Treatment with Bosutinib – Phase I/II

AAML1921: A Study of a Drug, Bosutinib, for Treating Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph+ Chronic Myeloid Leukemia

Protocol Description

Through this multi-center investigation by the Children’s Oncology Group, researchers will study how well bosutinib, when given at the most favorable dose, works in children with chronic myeloid leukemia (CML). Bosutinib is a tyrosine kinase inhibitor (TKI) that has a different side-effect profile than TKIs typically used in treatment of CML. TKIs help block the action of a type of protein kinase or enzyme called tyrosine kinase, which can help prevent the cancer cells from growing.

Study Level: I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 17, who have been diagnosed with CML.
Boys and Girls: Ages 1 through 17 years


The first part of the study is focused on determining the most favorable dose that can be given safely, and the second part monitors effects over a longer term. The drug will be taken orally over the course of multiple 28-day cycles with visits for examinations and tests during each of the first 7 cycles, then every third cycle thereafter.
Visits: Number varies based on participant response to therapy.
Duration: Depends on participant response to drug and may last up to 2 years after the last participant joins the first part of the study, with long-term follow-up for 10 years.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AAML1921)
National Cancer Institute

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: