Overview

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

Status:
Completed
Trial end date:
2022-04-06
Target enrollment:
0
Participant gender:
All
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 stopping their Tyrosine Kinase Inhibitor (TKI) medication.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical College of Wisconsin
Collaborators:
Barbara Ann Karmanos Cancer Institute
Dana-Farber Cancer Institute
Duke Cancer Institute
Emory University
Fred Hutchinson Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Memorial Sloan Kettering Cancer Center
University of California, San Francisco
University of Chicago
University of Utah
Weill Medical College of Cornell University
Treatments:
Dasatinib
Imatinib Mesylate
Tin Fluorides
Criteria
Inclusion Criteria:

1. Age 18 or older at time of study entry

2. Willing and able to give informed consent

3. 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

4. Currently taking imatinib, dasatinib, nilotinib or bosutinib

5. Patient has been on TKI therapy for at least 3 years

6. 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

7. 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

8. Two (2) Screening PCRs have been completed and both results are < 0.01% (>MR4 i.e > 4
log reduction) by central lab

9. Has been on any number of TKIs, but has not been resistant to any TKI (changes made
for intolerance are allowed)

10. Patient has been compliant with therapy per treating physician

Exclusion Criteria:

1. Prior hematopoietic stem cell transplantation

2. Poor compliance with taking TKI

3. Unable to comply with lab appointments schedule and PRO assessments

4. Life expectancy less than 36 months

5. Patients who have been resistant to previous TKI therapy are not eligible

6. Pregnant or lactating women