Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471478
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
The Combination of IVIG Dexamethasone and a Megadose of PBSCs for Decreasing DSAs
Sponsor:
Hematology department of the 920th hospital
Organization:
Hematology department of the 920th hospital
Study Overview
Official Title:
A Retrospective Study Using the Combination of IVIG Dexamethasone and a Megadose of PBSCs Transfusion for Decreasing DSAs During Haplo-HSCT
Status:
COMPLETED
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:
Donor-specific antibodies DSAs are essential causes of graft rejection in haploidentical hematopoietic stem cell transplantation haplo-HSCT DSAs are unavoidable for some patients who have no alternative donor Effective interventions to reduce DSAs are still needed and the cost of the current therapies is relatively high Investigators wanted to retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center and evaluated the therapeutic efficacy of the combination of intravenous immunoglobulin IVIG dexamethasone and megadose of transfused peripheral blood stem cells PBSCs for DSA desensitization
Detailed Description:
Investigators retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center All patients received 1 gkg IVIG on day -1 and 25 mgm2d dexamethasone on days -4-1 before transplantation and approximately three doses of PBSCs were transfused On the basis of the conventional transfusion amount of hematopoietic stem cells additional PBSCs were transfused based on the DSA level of each patient 32108kg 62108kg and 92108kg mononuclear cells for participants whose DSAs were weakly positive positive and strongly positive respectively
Blood samples from participants were collected at the following 5 time points before HSCT and 1 day 8 day 15 day and 22 day after transplantation
The primary endpoint was the incidence of PGF The secondary endpoints were the incidence of poor graft function acute and chronic GVHD relapse nonrelapse mortality NRM overall survival OS and disease-free survival DFS
Blood samples from participants were collected at the following 5 time points before HSCT and 1 day 8 day 15 day and 22 day after transplantation
The primary endpoint was the incidence of PGF The secondary endpoints were the incidence of poor graft function acute and chronic GVHD relapse nonrelapse mortality NRM overall survival OS and disease-free survival DFS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202301AY070001-226 | OTHER_GRANT | None | None |