Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477549
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Sponsor:
St Petersburg State Pavlov Medical University
Organization:
St Petersburg State Pavlov Medical University
Study Overview
Official Title:
Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
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:
None
Brief Summary:
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure Different technologies of with replete or depleted graft are associated with 7-20 of graft failures in different diseases Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure relapse and non-relapse mortality The stratas for the study are Disease Risk Index DRI and the age of the haploidentical donor 35 vs 35
Detailed Description:
None
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