NCT06450145

Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL

A Study to Explore the Efficacy and Safety of Interferon-α Combined With ATO and Venetoclax in the Treatment of Arsenic-resistant Acute Promyelocytic Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-arm, open study. After the screening period, arsenic-resistant APL patients were treated with interferon α-2b, arsenic and venetoclax. The efficacy (ORR) and safety were evaluated.

Detailed description

Eligible APL patients with arsenic-resistant relapse will enter the run-in period, and the subjects in the run-in phase will be treated with arsenic combined with venetoclax. After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to follow-up occurred. Tumor assessments were performed every 4 to 6 weeks (as determined by the investigator) during trial treatment. Those who achieved CR/PR/PD/ withdrawal were then returned to standard treatment (treatment regimen was determined by the clinician), and those who completed the combination treatment period of the trial entered the survival follow-up period.

Conditions

• Tumour

Interventions

Type	Name	Description
DRUG	interferon α-2b	Eligible APL patients with arsenic-resistant relapse will enter the run-in period, and the subjects in the run-in phase will be treated with arsenic combined with venetoclax. After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to follow-up occurred. Tumor assessments were performed every 4 to 6 weeks (as determined by the investigator) during trial treatment. Those who achieved CR/PR/PD/ withdrawal were then returned to standard treatment (treatment regimen was determined by the clinician), and those who completed the combination treatment period of the trial entered the survival follow-up period.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

2 sites across 1 country: China