Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date October 8, 2014
First Posted Date October 21, 2014
Last Update Posted Date March 12, 2020
Study Start Date December 2014
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: October 16, 2014)
  • Proportion of patients with CML who develop molecular recurrence after discontinuing TKIs [ Time Frame: Participants will be followed for the duration of the study, an expected average of 3 years ]
  • Patient-reported health status of patients before and after stopping TKIs [ Time Frame: Compare the patient-reported health status of patients before and after stopping TKIs, an expected average of 3 years ]
    We will collect and report patient-reported health status using the PROMIS scales covering the domains of fatigue, depression, sleep, GI symptoms, anxiety, physical function, pain, social function, sexual function, social isolation, and cognitive function. Where PROMIS measures are not available to assess CML-specific symptoms, the EORTC QLQ-CML Symptom Burden scale will be used.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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)
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Leukemia, Myeloid, Chronic
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Stopping their TKI
Publications * Atallah E, Schiffer CA, Weinfurt KP, Zhang MJ, Radich JP, Oehler VG, Pinilla-Ibarz J, Deininger MWN, Lin L, Larson RA, Mauro MJ, Moore JO, Ritchie EK, Shah NP, Silver RT, Wadleigh M, Cortes J, Thompson J, Guhl J, Horowitz MM, Flynn KE. Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia. BMC Cancer. 2018 Apr 2;18(1):359. doi: 10.1186/s12885-018-4273-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 16, 2014)
173
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02269267
Other Study ID Numbers PRO00023447
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ehab L Atallah, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
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
Investigators
Principal Investigator: Ehab Atallah, MD Medical College of Wisconsin
Principal Investigator: Kathryn Flynn, PhD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date March 2020