This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Age ≥18 years old.
Willing and able to give informed consent.
Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 ^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.
Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib, imatinib or nilotinib.
History of accelerated or blast phase CML.
A second malignancy requiring active treatment.
History of recent (within 12 months) acute pancreatitis or chronic pancreatitis.
Subjects who have previously received treatment with asciminib.
Single group
Asciminib 40 MG
Drug40 mg by mouth (PO) when used with imatinib.
Asciminib 40 MG Twice Daily
Drug40 mg twice daily when used with nilotinib.
Asciminib 80 MG daily
Drug80 mg daily when used with dasatinib or taken alone.
Imatinib
DrugMaximum dose of 400 mg PO once daily.
Nilotinib
DrugMaximum dose of 300 mg twice daily.
Dasatinib
DrugMaximum dose of 100 mg PO once daily.
One-year "second" treatment-free remission.
This will be measured by the number of subjects who achieve one-year treatment-free remission after 12 months of asciminib based therapy. These subjects have previously failed a first treatment free remission attempt.
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Medical College of Wisconsin
Lead sponsor
H. Jean Khoury Cure CML Consortium
Collaborator
