Spots Global Cancer Trial Database for The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
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Trial Identification
Brief Title: The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Official Title: The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Study ID: NCT02269267
Conditions
Study Description
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 stopping their Tyrosine Kinase Inhibitor (TKI) medication.
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) 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Helen Diller Family Comprehensive Cancer Center University of California, San Francisco, California, United States
Moffit Cancer Center, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
The University of Chicago, Chicago, Illinois, United States
The University of Chicago Medicine Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
Beth Israel Deaconess Medical Center (Satellite site of Dana Farber), Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute of Wayne State University, Detroit, Michigan, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Froedtert Hospital & Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Ehab Atallah, MD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
Name: Kathryn Flynn, PhD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
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