A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Orally, once every other day (QOD).
Orally, once daily (QD).
Royal North Shore Hospital
St Leonards, New South Wales, Australia
RECRUITINGRoyal Adelaide Hospital
Minimal residual disease negativity rate
The minimal residual disease negativity rate of olverembatinib combined chemotherapy versus imatinib combined chemotherapy in subjects with newly diagnosed Ph+ALL.
Time frame: Cycles 1 to cycle 3 (each cycle is 28 days)
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 were assessed.
Time frame: Through study completion,an average of 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)
The patients' score of EORTC(The European Organization for Research and Treatment of Cancer) QLQ-C30.
To evaluate patient-reported outcome in patients treated with olverembatinib plus chemotherapy.(The scale ranges from 0 to 100, with a lower score indicating better quality of life and a higher score on the scale indicating worse symptoms.)
Time frame: Through study completion,an average of 2 years.
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Adelaide, South Australia, Australia
Alfred Health
Melbourne, Victoria, Australia
RECRUITINGRoyal Perth Hospital
Perth, Washington, Australia
RECRUITINGThe First Affiliated Hospitalo of Bengbu Medical School
Bengbu, Anhui, China
NOT_YET_RECRUITINGXinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGuangdong Province People's Hospital
Guangdong, Guangzhou, China
NOT_YET_RECRUITINGNanfang Hospital of Southern Medical University
Guangdong, Guangzhou, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGWuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 4 more locations