Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450145
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-30
Brief Title:
Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL
Sponsor:
Zhejiang Provincial Peoples Hospital
Organization:
Zhejiang Provincial Peoples Hospital
Study Overview
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APL
Brief 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 CRPRPD deathwithdrawalloss to follow-up occurred Tumor assessments were performed every 4 to 6 weeks as determined by the investigator during trial treatment Those who achieved CRPRPD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None