Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177561
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
Status:
RECRUITING
Status Verified Date:
2023-11
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 aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation
Detailed Description:
We recruited 38 patients according to the inclusion criteriaInclusion criteria 1 Serum DSA positive MFI 2000Between the ages of 18 and 65 male and female are not limitedPlanned to undergo allo-HSCT with an estimated survival time of3 months and an ECOG physical fitness score of 0-2Normal renal function BUN Cr 15 times the upper limit of normal value Ccr80mlmin 2 Normal liver function defined as ALT and AST 15 times the upper limit of normal 3 TBiL 15 times the upper limit of normal 4 ECG did not indicate any AMI arrhythmia or IAVB 5 No CI defined as LVEF 50 normal MYO and BNP 6 Non active RHD 7 Chest X-ray or physical examination did not indicate cardiac dilatation 8 Normal lung function defined as FEV1 FVC DLCO 60 predicted value
Sample the peripheral blood of the patient at four timepointsBefore LPE treatment D0 Before stem cell transfusion On the 10th day of stem cell transfusionOn the 30th day of stem cell transfusionUsing multiplex bead analysis on the Luminex platform Luminex Corporation Austin TX USA including the LAB screening PRA and LAB screening hybrid method all patients ethylenediamine tetraacetic acid EDTA-treated serum was tested for anti-HLA class I and class II antibodiesAccording to the manufacturers instructions the semi-quantitative measurement of DSA levels was performed by LAB screening single antigen beads assay One Lambda ThermoFisher and the results were expressed as MFIThe cumulative DSA MFI was calculated by summing the MFI of all detected DSA under HLA antigen resolution
Evaluate the effectiveness of LPE by comparing it with the historical control group that has undergone TPE treatment in the past
Sample the peripheral blood of the patient at four timepointsBefore LPE treatment D0 Before stem cell transfusion On the 10th day of stem cell transfusionOn the 30th day of stem cell transfusionUsing multiplex bead analysis on the Luminex platform Luminex Corporation Austin TX USA including the LAB screening PRA and LAB screening hybrid method all patients ethylenediamine tetraacetic acid EDTA-treated serum was tested for anti-HLA class I and class II antibodiesAccording to the manufacturers instructions the semi-quantitative measurement of DSA levels was performed by LAB screening single antigen beads assay One Lambda ThermoFisher and the results were expressed as MFIThe cumulative DSA MFI was calculated by summing the MFI of all detected DSA under HLA antigen resolution
Evaluate the effectiveness of LPE by comparing it with the historical control group that has undergone TPE treatment in the past
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