The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
a third-generation TKI
a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Glucocorticoids
Anti-tumor alkaloids
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
CMR rate
Complete molecular remission rate (CMR rate) at 3 months of treatment (90 days)
Time frame: At 3 months of treatment (90 days)
Overall survival(OS)
From the date of registration to the date of death resulting from any cause
Time frame: up to 60 months
Relapse free survival
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day
Time frame: up to 60 months
The rate of adverse events
Time frame: an expected average of 24 months
complete remission (CR) rate
Time frame: an expected average of 3 months
The duration of CR
Time frame: up to 60 months
The duration of molecular CR
Time frame: up to 60 months
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