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

Tumour Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tumour

• NCT number: NCT06450145
• Study type: Interventional
• Source: Zhejiang Provincial People's Hospital
• Contact: Rui Hao
• Phone: 15957145619
• Email: hao61977@163.com
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: December 31, 2025