The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.
PRIMARY OBJECTIVES: To determine the Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates, the measurable residual disease (MRD) rates, the complete molecular remissions (CMR) rates and the progression-free survival (PFS) of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL. SECONDARY OBJECTIVES: To describe the toxicities of the OVD regimen. To assess the quality of life and overall survival of the OVD chemotherapy-free regimen in patients with newly-diagnosed Ph+ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28
Department of Hematology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, China
RECRUITINGComplete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Time frame: Three years
Negative measurable residual disease (MRD) rates
Time frame: Three years
Complete molecular remissions (CMR) rates
Time frame: Three years
Progression-free survival (PFS)
Time frame: Three years
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