The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs
- Conditions
- Blood Disease
- Registration Number
- NCT06471478
- Lead Sponsor
- Hematology department of the 920th hospital
- 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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
DSA positive, receive HSCT in our hospital. -
Have alternative DSA-negative donor, expended life-span less than 1 month.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft failure Rate 2 years Number of patients who did not have graft engraftment. Graft failure was defined as the return of recipient hematopoiesis as confirmed by chemerism analysis as \<%% donor chimerism at +28 day after HSCT
- Secondary Outcome Measures
Name Time Method disease free survival 2 years poor graft function rate 2 years Number of patients who have \>95% donor chinerism but blood morphology does not return.
acute graft-versus-host disease rate 2 years the incidence of patients who developed aGVHD
nonrelapse mortality 2 years overall survival 2 years chronic graft-versus-host disease rate 2 years the incidence of patients who developed cGVHD
Trial Locations
- Locations (1)
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
🇨🇳Kunming, Yunnan, China