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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02269267
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : March 12, 2020
Sponsor:
Collaborators:
University of Chicago
University of California, San Francisco
University of Utah
Dana-Farber Cancer Institute
Emory University
Barbara Ann Karmanos Cancer Institute
Duke Cancer Institute
Fred Hutchinson Cancer Research Center
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
Ehab L Atallah, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment
Leukemia, Myeloid, Chronic Other: Stopping their TKI

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.

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Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Study Start Date : December 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Discontinuation of TKI medication
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.
Other: Stopping their TKI
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. 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.




Primary Outcome Measures :
  1. Proportion of patients with CML who develop molecular recurrence after discontinuing TKIs [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 months ]
    The number of patients who develop molecular recurrence after discontinuing TKIs.

  2. Patient-reported health status related to fatigue of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  3. Patient-reported health status related to depression of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of depression using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  4. Patient-reported health status related to sleep of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  5. Patient-reported health status related to GI symptoms of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of GI symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  6. Patient-reported health status related to anxiety of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of anxiety symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  7. Patient-reported health status related to physical function of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of physical function symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  8. Patient-reported health status related to pain of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of pain symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  9. Patient-reported health status related to social function of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of social function using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  10. Patient-reported health status related to sexual function of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of sexual function using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  11. Patient-reported health status related to social isolation of patients before and after stopping TKIs [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of social isolation using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  12. Patient-reported health status related to cognitive function of patients before and after stopping TKIs. [ Time Frame: Before and 3 years stopping TKIs. ]
    Patient-reported health status of cognitive function using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales.

  13. Patient-reported health status. [ Time Frame: Before and 3 years stopping TKIs. ]
    In outcomes two through 12, if the PROMIS scale cannot be used, then the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -CML Symptom Burden scale will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269267


Locations
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United States, California
Helen Diller Family Comprehensive Cancer Center University of California
San Francisco, California, United States, 94143
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
The University of Chicago Medicine Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
United States, Massachusetts
Beth Israel Deaconess Medical Center (Satellite site of Dana Farber)
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute of Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Weill Medical College of Cornell University
New York, New York, United States, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77054
United States, Utah
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132-2408
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
University of Chicago
University of California, San Francisco
University of Utah
Dana-Farber Cancer Institute
Emory University
Barbara Ann Karmanos Cancer Institute
Duke Cancer Institute
Fred Hutchinson Cancer Research Center
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Ehab Atallah, MD Medical College of Wisconsin
Principal Investigator: Kathryn Flynn, PhD Medical College of Wisconsin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ehab L Atallah, Associate Professor (Principal Investigator), Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02269267    
Other Study ID Numbers: PRO00023447
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs