Chronic Myeloid Leukemia Remission without TKI Medication – Phase II

AAML18P1: Stopping Tyrosine Kinase Inhibitors to Assess Treatment-Free Remission in Pediatric Chronic Myeloid Leukemia - Chronic Phase

Protocol Description

Through this multi-center study by the Children’s Oncology Group, researchers will assess whether continuing on tyrosine kinase inhibitors (TKI) is necessary for children, adolescents and young adults whose chronic-phase chronic myeloid leukemia (CML-CP) is in remission. The standard treatment for CML is to take TKI medication daily for life, however, studies have shown that about 40% of adult CML-CP patients can maintain molecular remission status after stopping TKI medication.

Study Level: II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients up to age 25 who were diagnosed with CML-CP before the age of 18.
Males and Females: Up to 25 years of age


All study participants will be asked to stop taking their TKI medication. Ongoing clinic visits will be scheduled for testing to monitor disease status. Visit frequency decreases each year over 3 years. If at any time loss of molecular remission is detected, participants will restart TKI medication, with visits and monitoring continuing per the research study’s 3-year protocol.
Visits: Every 4 weeks in Year 1, every 6 weeks in Year 2, and every 12 weeks in Year 3
Duration: 3 years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AAML18P1)
National Cancer Institute

Primary Investigator

Jean M. Tersak, 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: