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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:December 2014
End Date:December 2021

Use our guide to learn which trials are right for you!

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.

This is a non-randomized, prospective, single-group longitudinal study. The overall objective
is to improve decision making for TKI discontinuation in eligible CML patients. Patients with
CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep
molecular response will stop their TKI. Confirmed deep molecular response is defined as
BCR-ABL < 0.01%, (> MR4 i.e. > 4 log reduction) for at least 2 years. The study will closely
monitor patients using standard RQ-PCR testing for molecular recurrence, testing them monthly
for 6 months, then every other month until 24 months, and then quarterly until 36 months.
Concurrently, the study will assess a wide range of PROs before stopping TKIs and after
discontinuation in conjunction with PCR testing, though at fewer time points, utilizing
online and/or phone questionnaires. Patients who have molecular CML recurrence based on
RQ-PCR will restart imatinib, dasatinib, nilotinib, or bosutinib and will continue to be
monitored for disease status and health status until the end of the study.

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
We found this trial at
16
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Joseph Moore, MD
Phone: 919-681-4769
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: James E Thompson, MD
Phone: 716-845-1073
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Richard Larson, MD
Phone: 773-702-4936
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Vivian Oehler, MD
Phone: 206-667-1340
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Jean Khoury, MD
Phone: 404-778-4334
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4912
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Boston, MA
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Detroit, Michigan
Principal Investigator: Charles Schiffer, MD
Phone: 313-576-9689
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Detroit, MI
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Houston, Texas 77030
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Houston, TX
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Milwaukee, WI
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New Lenox, IL
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445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Richard Silver, MD
Phone: 212-746-4882
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-3107
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Salt Lake City, Utah 84112
Principal Investigator: Michael Deininger, MD
Phone: 801-585-3229
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Salt Lake City, UT
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San Francisco, California 94143
Principal Investigator: Neil P. Shah, MD, PhD
Phone: 415-353-2421
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Tampa, Florida 33612
Principal Investigator: Javier Pinilla-Ibarz, MD, PhD
Phone: 813-745-3304
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Tampa, FL
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