Viewing Study NCT04713956



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Last Modification Date: 2024-10-26 @ 1:54 PM
Study NCT ID: NCT04713956
Status: UNKNOWN
Last Update Posted: 2021-01-19
First Post: 2021-01-15

Brief Title: G-CSFDACBUCY vs G-CSFDACBF Conditioning Regimen for RAEB-1REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Sponsor: Nanfang Hospital Southern Medical University
Organization: Nanfang Hospital Southern Medical University

Study Overview

Official Title: G-CSFDACBUCY vs G-CSFDACBF 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-CSFDACBUCY and G-CSFDACBF 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-CSFDACBUCY 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-CSFDACBUCY and G-CSFDACBF conditioning regimens in RAEB-1 REAB-2 and AML secondary to MDS undergoing allo-HSCT

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