NCT05594784

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Olverembatinib	a third-generation TKI
DRUG	Venetoclax	a selective inhibitor of B-cell lymphoma 2 (Bcl-2)
DRUG	prednisone	Glucocorticoids
DRUG	Vincristine	Anti-tumor alkaloids

Timeline

• Start date: 2022-10-08
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2022-10-26
• Last updated: 2025-06-03

Locations

1 site across 1 country: China