Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04713956
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.
Detailed Description:
Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT.
Study Oversight
Has Oversight DMC:
True
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?: