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Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL
Sponsor: Zhejiang Provincial People's Hospital
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-05-01
Completion Date
2025-12-31
Last Updated
2024-06-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China