LAST Stopping Tyrosine kinase inhibitors

What is the purpose of the study

They are considering stopping their tyrosine kinase inhibitor (TKI) medication. Patients with CML who are on imatinib, dasatinib, nilotinib, or bosutinib and have had undetectable BCR-ABL by PCR for at least 2 years will stop their tyrosine kinase inhibitor medication.

The study will closely monitor patients for molecular recurrence of their disease after stopping their tyrosine kinase inhibitor medication. Patients will have PCR testing every month for the 1st year, then every other month for the 2nd year, and then every 3 months for the 3rd year. Patients will also answer questions about their symptoms and quality of life before and after stopping their tyrosine kinase inhibitor, on a similar schedule to the PCR testing. Patients who have molecular CML recurrence will restart imatinib, dasatinib, nilotinib, or bosutinib and will continue to be monitored for disease status and patient-reported health status until the end of the study.

Key inclusion criteria

This study includes patients 18 years and older diagnosed with chronic myeloid leukemia (CML) in chronic phase. To be eligible for inclusion, patients will currently be taking imatinib, dasatinib, nilotinib or bosutinib. They will have been taking tyrosine kinase inhibitors for at least 3 years.

Patients are eligible if they have documented undetectable BCR-ABL by PCR for at least 2 years before screening, according to their local lab. Patients who enroll will have two screening PCRs by central lab before stopping their tyrosine kinase inhibitor.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

United States

Florida
Moffitt Cancer Center
Tampa, FL

Georgia
Winship Cancer Institute of Emory University
Atlanta, GA

Illinois
University of Chicago Comprehensive Cancer Center
Chicago, IL

Massachussetts
Dana-Farber Cancer Institute,
Boston, MA

Michigan
Karmanos Cancer Institute of Wayne State University
Detroit, MI

New York
Memorial Sloan Kettering Cancer Center
New York, NY

North Carolina
Duke University Cancer Institute
Durham, NC

Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

Washington
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Seattle, WA

Wisconsin
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin