Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation A Single-Centre Single-Arm Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation
Detailed Description:
Approximately 10-21 of allogeneic hematopoietic stem cell transplantation allo-HSCT patients have non-specific or donor-specific anti-HLA antibodies DSAs prior to transplantation Patients with combined DSAs and mean fluorescence intensity MFI 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation and increased transplant-related mortality TRM Meanwhile a retrospective study at our centre found that patients with high titre non-specific antibodies MFI 5000 present before cord blood transplantation had significantly higher TRM in the early post-transplantation period Therefore our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patients body reduce the incidence of transplant-related complications and improve the prognosis of transplantation
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?:
False
Is an FDA AA801 Violation?:
None