NCT06471478

The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs

A Retrospective Study Using the Combination of IVIG, Dexamethasone and a Megadose of PBSCs Transfusion for Decreasing DSAs During Haplo-HSCT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Hematology department of the 920th hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 g/kg IVIG on day -1 and 25 mg/m2/d 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: 3±2×108/kg, 6±2×108/kg and 9±2×108/kg 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).

Conditions

• Blood Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion	patients received intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion for decresing donor specific antibodies.

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-10-30
• Completion: 2023-08-30
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: China