The LAST Study - The Life After Stopping Tyrosine Kinase Inhibitors Study [USA]
The Life After Stopping Tyrosine Kinase Inhibitors Study (ClinicalTrials.gov No. NCT02269267)
Indication and most important 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.
Short description of intervention
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.
Type of study
Treatment discontinuation trials
In a single country
Medical College of Wisconsin with National Institutes of Health (NIH) grant 1R01CA184798-01A1
Scientific lead / contact
Ehab Atallah, Medical College of Wisconsin
Kathryn Flynn, Medical College of Wisconsin
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Moffitt Cancer Center
Winship Cancer Institute of Emory University
University of Chicago Comprehensive Cancer Center
Dana-Farber Cancer Institute,
Karmanos Cancer Institute of Wayne State University
Memorial Sloan Kettering Cancer Center
New York, NY
Duke University Cancer Institute
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Froedtert Hospital & Medical College of Wisconsin