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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated 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 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.

Keywords

Leukemia, Myeloid, Chronic Tin Fluorides

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of Utah Huntsman Cancer Institute
    Salt Lake City, Utah, 84132-2408, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington, 98109-1024, United States
  • MD Anderson Cancer Center
    Houston, Texas, 77054, United States
  • Froedtert Hospital & Medical College of Wisconsin
    Milwaukee, Wisconsin, 53226, United States
  • The University of Chicago Medicine Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois, 60451, United States
  • The University of Chicago
    Chicago, Illinois, 60637, United States
  • Karmanos Cancer Institute of Wayne State University
    Detroit, Michigan, 48201, United States
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia, 30322, United States
  • Roswell Park Cancer Institute
    Buffalo, New York, 14263, United States
  • Moffit Cancer Center
    Tampa, Florida, 33612, United States
  • Duke University Medical Center
    Durham, North Carolina, 27710, United States
  • Weill Medical College of Cornell University
    New York, New York, 10021, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York, 10065, United States
  • Beth Israel Deaconess Medical Center (Satellite site of Dana Farber)
    Boston, Massachusetts, 02215, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts, 02215, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medical College of Wisconsin
ID
NCT02269267
Phase
Phase 2
Lead Scientist
Neil Pravin Shah
Study Type
Interventional
Last Updated
September 1, 2017