Inclusion Criteria |
Age 18 or older |
Willing and able to give informed consent |
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 |
Currently taking imatinib, dasatinib, nilotinib or bosutinib |
Has been on TKI therapy for at least 3 years |
Documented BCR-ABL < 0.01% or undetectable BCR-ABL by RQ-PCR for at least 2 years according to the patient’s local lab |
Documented BCR-ABL < 0.01% or undetectable BCR-ABL by RQ-PCR at least 3 times prior to screening according to the patient’s local lab |
Two (2) Screening PCRs have been completed and both results are < 0.01% (better than MR4, i.e,. > 4 log reduction) by central lab |
Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed) |
Has been compliant with therapy per treating physician |
Exclusion Criteria |
Prior hematopoietic stem cell transplantation |
Poor compliance with taking TKI |
Unable to comply with lab appointments schedule and PRO assessments |
Life expectancy less than 36 months |
Resistant to previous TKI therapy |
Pregnant or lactating women |