Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05603884
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2022-10-29
Brief Title:
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia AML
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
Venetoclax Combining Chidamide and Azacitidine VCA Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone Cytarabine and G-CSF D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia AML A Multicenter Prospective Single Arm Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine VCA Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia AML
Detailed Description:
Elderly Patients with AML have inferior outcomes due to poor physical condition and intolerant to conventional chemotherapy The regimen of Venetoclax and Azacitidine has been widely used in these patients and has proved to achieve higher CR rate than low intensity therapy However the median duration of response DOR of this regimen is about one year Chidamide is a histone deacetylase HDAC inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines The Venetoclax Combining Chidamide and Azacitidine VCA regimen was applied to one 62-year-old male patient with AML who achieved CR Meanwhile Liposome mitoxantrone has better safety and tolerance than mitoxantrone in elderly patients Thus this study is intended to use 2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens and then repeat the above four courses of treatment once to improve the median event free survival of elderly AML patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ChiCTR2200061925 | REGISTRY | Chinese clinical trial registry | None |