A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
olverembatinib QOD
Bosutnib QD
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMMR rate Part A
To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
Time frame: 24 weeks
MMR rate Part B
To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation
Time frame: 24 weeks
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