The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
Condition: Leukemia, Myeloid, Chronic
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Imatinib (Stopping their TKI); Dasatinib (Stopping their TKI); Nilotinib (Stopping their TKI); Bosutinib (Stopping their TKI)
Intervention description: Patients with CML on treatment with imatinib 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.; Patients with CML on treatment with dasatinib 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.; Patients with CML on treatment with nilotinib 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.; Patients with CML on treatment with 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.
Intervention MeSH terms: Imatinib Mesylate; Dasatinib; Tin Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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