Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

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.

Timeline

Start

2022-10-08

Primary completion

2025-03-25

Completion

2025-03-25

Publications

• Gong X, Liu W, Liu Y, Fang Q, Gu R, Liu K, Lin D, Zhou C, Zhang G, Gong B, Wei S, Li Y, Li S, Wang Y, Hu Y, Qiu S, Liu B, Wang Y, Mi Y, Wei H, Wang J. Olverembatinib combined with venetoclax and reduced-intensity chemotherapy for adult newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia: a single-center, single-arm, phase 2 trial. Leukemia. 2025 Aug;39(8):1838-1847. doi: 10.1038/s41375-025-02674-8. Epub 2025 Jun 30.

Drugs

Indications