NCT07517510

HVA in the Treatment of Mixed-Phenotype Acute Leukemia(MPAL).

The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine (HVA) in the Treatment of Mixed-Phenotype Acute Leukemia (MPAL), a Multicenter, Prospective, Single-arm Trial

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Guangdong Second Provincial General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of homoharringtonine combined with venetoclax and azacitidine regimen (HVA) in newly diagnosed MPAL patients, providing a basis for the use of the HVA regimen in the treatment of MPAL.

Detailed description

Our preliminary studies show that MPAL not only highly expresses BCL-2, but also highly expresses MCL-1, suggesting the need to explore combining MCL-1 inhibitors on the basis of Ven and HMAs. Our preliminary research confirmed that homoharringtonine (HHT) significantly enhances the anti-leukemia effect of Ven/AZA via inhibition of MCL-1. Originally, we designed the HVA regimen by combining HHT with Ven/AZA for the treatment of AML, and achieved better efficacy and safety. Then we exploratively treated 11 MPAL patients with HVA regimen and acquired promising response and safety. In this study, we conduct a multicenter, prospective, single arm trial to evaluate the efficacy and safety of HVA in the treatment of newly diagnosed MPAL.

Conditions

• Newly Diagnosed Mixed Phenotype Acute Leukemia (MPAL)

Interventions

Type	Name	Description
DRUG	HVA	HVA regimen: Venetoclax: 100 mg on day 1, 200 mg on Day 2, 400 mg per day from Day 3 to Day 14; Azacitidine: 75 mg/m2 per day by subcutaneous injection from Day 1 to Day 7; Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7. If co-administered with CYP3A inhibitors, the dose of venetoclax was adjusted in accordance with prescribing recommendations. Fms-related receptor tyrosine kinase 3 (FLT3) inhibitors were recommended in patients with FLT3-ITD/TKD mutations. Also tyrosine kinase inhibitors were recommended in patients with BCR/ABL-positive.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: China