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LAST Stopping Tyrosine kinase inhibitors

Study title

The LAST Study - The Life After Stopping Tyrosine Kinase Inhibitors Study [USA]

Scientific title

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

Current status

Recruiting

Study sponsor

Medical College of Wisconsin with National Institutes of Health (NIH) grant 1R01CA184798-01A1

Scientific lead / contact

Ehab Atallah, <mailto:>
Kathryn Flynn, <mailto:>

Principal investigator

Ehab Atallah, Medical College of Wisconsin
Kathryn Flynn, Medical College of Wisconsin

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

 

 


John A. Russell Community Builder Avatar   19.07.2017 (02:12:20)
Life After Stopping Tyrosine Kinase Inhibitors Study Yes No Are you still accepting patients in this trial? I have been on Gleevec for 15 years with complete molecular response and I am looking for a clinical trial to stop taking the medicine. Thank you.
 
Celia Marin Community Builder Avatar   19.07.2017 (17:39:42)
Question about LAST Study Clinical Trial Yes No Dear John,
Thank you so much for contact with us. Regarding your question, patients should consult their doctor for personal advice and/or their scientific contact/study staff for the most up-to-date study information. In this case, we propose you to email to the scientific contact of the clinical trial, Ehab Atallah or Kathryn Flynn to confirm this trial is still recruiting and receive the proper information that you may need.
We wish you the best and thank you again for following us.
Celia Marin
CML Advocates Network Programme Manager