Myeloproliferative Neoplasms Clinical Trial
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
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.
Full 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) 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 (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. The study will closely monitor patients using standard real-time Quantitative Polymerase Chain Reaction (RQ-PCR) testing for molecular recurrence, testing them monthly for six months, then every other month until 24 months, and then quarterly until 36 months. Concurrently, the study will assess a wide range of patient-reported outcomes (PROs) before stopping TKIs and after discontinuation in conjunction with Polymerase Chain Reaction (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.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There are 15 Locations for this study
San Francisco California, 94143, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
New Lenox Illinois, 60451, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Houston Texas, 77054, United States
Salt Lake City Utah, 84132, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
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