NCT06082934

Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia

An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Olverembatinib plus venetoclax and dexamethasone	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

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China