At a glance
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Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Olverembatinib, Venetoclax, and 2 other interventions for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Completed, enrolled 79 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
a third-generation TKI
a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Glucocorticoids
Anti-tumor alkaloids