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Recruiting
NCT06236724
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Conditions: Chronic Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 150
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Eligibility Criteria
Inclusion Criteria:
* Adult participants age ≥18 years.
* Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months).
* Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:
* Early chronic phase: time from diagnosis to therapy ≤12 months Late chronic phase: time from diagnosis to therapy \>12 months
* Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow
* Accelerated phase CML: presence of any of the following features:
i. Peripheral or marrow blasts 15% or more ii. Peripheral or marrow basophils 20% or more iii. Thrombocytopenia \
Source: ClinicalTrials.gov (NCT06236724). StuddyBuddy aggregates publicly available trial information.