The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
a study on Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedestimated completion
Description
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.
Details
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.
Keywords
Leukemia, Myeloid, Chronic Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Tin Fluorides Stopping their TKI Discontinuation of TKI medication
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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
Locations
- Helen Diller Family Comprehensive Cancer Center University of California
San Francisco California 94143 United States - University of Utah Huntsman Cancer Institute
Salt Lake City Utah 84132-2408 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Medical College of Wisconsin
- ID
- NCT02269267
- Study Type
- Observational
- Last Updated