Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
333
olverembatinib QOD
Bosutnib QD
24-Week MMR Rate (Part A)
To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib
Time frame: 24 weeks
24-Week MMR Rate (Part B)
To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation
Time frame: 24 weeks
96-Week MMR Rate (Part A)
To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib
Time frame: 96 weeks
96-Week MMR Rate (Part B)
To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation
Time frame: 96 weeks
Cytogenic Response Rate (Part A)
To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.
Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Cytogenic Response Rate (Part B)
To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation
Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Progression Free Survival (PFS) (Part A)
To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib
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Ascentage Investigative Site #1044
Birmingham, Alabama, United States
RECRUITINGAscentage Investigative Site #1112
Anchorage, Alaska, United States
RECRUITINGAscentage Investigative Site #1111
Goodyear, Arizona, United States
RECRUITINGAscentage Investigative Site #1062
Duarte, California, United States
RECRUITINGAscentage Investigative Site #1099
Irvine, California, United States
RECRUITINGAscentage Investigative Site #1075
La Jolla, California, United States
RECRUITINGAscentage Investigative Site #1100
Long Beach, California, United States
RECRUITINGAscentage Investigative Site #1059
Los Angeles, California, United States
RECRUITINGAscentage Investigative Site #1121
Sacramento, California, United States
RECRUITINGAscentage Investigative Site #1109
Upland, California, United States
RECRUITING...and 153 more locations
Time frame: 5 years after the last patient received the first study dose
Progression Free Survival (PFS) (Part B)
To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation
Time frame: 5 years after the last patient received the first study dose
Overall Survival (OS) (Part A)
To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib
Time frame: 5 years after the last patient received the first study dose
Overall Survival (OS) (Part B)
To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation
Time frame: 5 years after the last patient received the first study dose
Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)
According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.
Time frame: 96 weeks after the last patient received the first study dose
Characterization of population pharmacokinetics of olverembatinib (Parts A and B)
Blood samples will be collected to measure the plasma concentration of olverembatinib
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)