A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Oral (PO) once every other day (QOD).
Oral (PO) once daily (QD).
Minimal Residual Disease Negative CR Rate
The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)
Event-free Survival (EFS)
EFS is defined as the time from study randomization to the date of treatment failure (ITF), relapse from CR, or death from any cause, whichever comes first.
Time frame: Baseline up to 3 to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug will be assessed.
Time frame: Through study completion (approximately 2 years)
Plasma concentrations of olverembatinib
Blood samples will be collected to measure the plasma concentration of olverembatinib.
Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)
FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score
To evaluate health-related Quality of Life (HR-QoL) in patients treated with olverembatinib plus chemotherapy.
Time frame: Through study completion (approximately 2 years)
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Ascentage Investigative Site #1044
Birmingham, Alabama, United States
NOT_YET_RECRUITINGAscentage Investigative Site #1062
Duarte, California, United States
NOT_YET_RECRUITINGAscentage Investigative Site #1134
Los Angeles, California, United States
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Los Angeles, California, United States
NOT_YET_RECRUITINGAscentage Investigative Site #1142
Miami, Florida, United States
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Augusta, Georgia, United States
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Indianapolis, Indiana, United States
NOT_YET_RECRUITINGAscentage Investigative Site #1069
Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Hackensack, New Jersey, United States
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