Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
M.D. Anderson Cancer Center
Summary
To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.
Description
Primary Objectives * To assess the rate of MMR by 12 months. Secondary Objectives * To assess the rate of CCyR 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 sustained deep molecular response. * To estimate event-free survival and overall survival. * To assess the toxicity of olverembatinib monotherapy. * To assess health-related quality of life (HRQOL) of the participants.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria: * Adult participants age ≥18 years. * Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase. * 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: total bilirubin ≤1.5x ULN (unless s…
Interventions
- Drugolverembatinib
GIven by PO
Location
- MD Anderson Cancer CenterHouston, Texas