Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06073730
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-10-03
Brief Title:
Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine DEC3-VEN vs Venetoclax in Combination With Azacitidine VIALE-A in the Treatment of Elderly Patients or Unfit New-diagnosis Acute Myeloid Leukemia Patients
Sponsor:
The Second Affiliated Hospital of Kunming Medical University
Organization:
The Second Affiliated Hospital of Kunming Medical University
Study Overview
Official Title:
Department of Hematology The Second Affiliated Hospital of Kunming Medical University
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
Combining the results of previous studies and based on the clinical practice in our center we designed the Venetoclax in combination with 3days-Decitabine regimen for induction therapy in elderly or unfit AML patients with a primary diagnosis and set Venetoclax in combination with Azacitidine VIALE-A as a control group to compare the efficacy and safety and to provide evidence for the optimal selection of the clinical treatment regimen
PRIMARY ENDPOINT To assess whether Venetoclax in combination with 3 days-diascitabine versus standard dose Venetoclax in combination with azacitidine improves event-free survival EFS in elderly or adult patients with unfit AML during the maximum follow-up period Event-free survival was defined as the absence of events such as treatment failure intolerance withdrawal all-cause death or achievement of CR or CRi or relapse after MLFS whichever occurred first between patients randomization and the maximum follow-up period Treatment failure was defined as failure to achieve CR or CRi MLFS after 2 courses of induction therapy
PRIMARY ENDPOINT To assess whether Venetoclax in combination with 3 days-diascitabine versus standard dose Venetoclax in combination with azacitidine improves event-free survival EFS in elderly or adult patients with unfit AML during the maximum follow-up period Event-free survival was defined as the absence of events such as treatment failure intolerance withdrawal all-cause death or achievement of CR or CRi or relapse after MLFS whichever occurred first between patients randomization and the maximum follow-up period Treatment failure was defined as failure to achieve CR or CRi MLFS after 2 courses of induction therapy
Detailed Description:
Induction therapy regimen
A Experimental group Venetoclax in combination with Decitabine -sorafenib Venetoclax VEN 100mg d1 200mg d2 400mg d3-14 Decitabine DEC 20mgm2q8h d4-6 infusion time 2h Sorafenib 600mgd d8-14 FLT3ITD mutation positive patients B Control standard dose of Venetoclax Azacitidine Venetoclax VEN 100mg d1 200mg d2 400mg d3-28 Azacitidine AZA 75mgm2d d3-9
Post-remission treatment regimen
A Experimental group Venetoclax combined with Decitabine Venetoclax VEN 400mgd d1-7 Decitabine DEC 20mgm2q8h d2-3 this regimen is repeated every 4-6 weeks B Control Group Venetoclax combined with Azacitidine Venetoclax VEN 100mg d1 200mg d2 400mgd d3-28 Azacitidine AZA 75mgm2d d3-9 this regimen is repeated every 4-6 weeks
A Experimental group Venetoclax in combination with Decitabine -sorafenib Venetoclax VEN 100mg d1 200mg d2 400mg d3-14 Decitabine DEC 20mgm2q8h d4-6 infusion time 2h Sorafenib 600mgd d8-14 FLT3ITD mutation positive patients B Control standard dose of Venetoclax Azacitidine Venetoclax VEN 100mg d1 200mg d2 400mg d3-28 Azacitidine AZA 75mgm2d d3-9
Post-remission treatment regimen
A Experimental group Venetoclax combined with Decitabine Venetoclax VEN 400mgd d1-7 Decitabine DEC 20mgm2q8h d2-3 this regimen is repeated every 4-6 weeks B Control Group Venetoclax combined with Azacitidine Venetoclax VEN 100mg d1 200mg d2 400mgd d3-28 Azacitidine AZA 75mgm2d d3-9 this regimen is repeated every 4-6 weeks
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