Status:
COMPLETED
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
University of Chicago
University of California, San Francisco
Conditions:
Leukemia, Myeloid, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a non-randomized, prospective, single-group longitudinal study. The purpose of this study is to improve the decision making process used by physicians and patients when they are considering st...
Detailed Description
This is a non-randomized, prospective, single-group longitudinal study. The overall objective is to improve decision making for TKI discontinuation in eligible chronic myelogenous leukemia (CML) patie...
Eligibility Criteria
Inclusion
- Age 18 or older at time of study entry
- Willing and able to give informed consent
- Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein
- Currently taking imatinib, dasatinib, nilotinib or bosutinib
- Patient has been on TKI therapy for at least 3 years
- Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL by PCR for at least 2 years according to the patient's local lab
- Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL at least 3 times prior to screening according to the patient's local lab
- Two (2) Screening PCRs have been completed and both results are \< 0.01% (\>MR4 i.e \> 4 log reduction) by central lab
- Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
- Patient has been compliant with therapy per treating physician
Exclusion
- Prior hematopoietic stem cell transplantation
- Poor compliance with taking TKI
- Unable to comply with lab appointments schedule and PRO assessments
- Life expectancy less than 36 months
- Patients who have been resistant to previous TKI therapy are not eligible
- Pregnant or lactating women
Key Trial Info
Start Date :
December 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT02269267
Start Date
December 18 2014
End Date
April 6 2022
Last Update
March 3 2023
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Helen Diller Family Comprehensive Cancer Center University of California
San Francisco, California, United States, 94143
2
Moffit Cancer Center
Tampa, Florida, United States, 33612
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
The University of Chicago
Chicago, Illinois, United States, 60637