Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
M.D. Anderson Cancer Center
Summary
To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Description
Primary Objectives: • To assess the rate of major molecular response (MMR) by 12-months. Secondary Objectives: * To assess the rate of complete cytogenetic response (CCyR, or PCR ≤ 1% IS) by 12 months * To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6-, 12-,18-, 24-, and 36 months of therapy. * To estimate the rate of TFR * To estimate the time to progression, progression-free survival, and overall survival. * To assess the toxicity of this dosing schedule by evaluating the adverse events that occur while the participant is on asciminib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 \<30 days are eligible. * Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study. * ECOG performance status ≤2. * Participants must have adequate end organ function, defined as the following:…
Interventions
- DrugAsciminib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas