Blood Disease
Conditions
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).
Interventions
COMBINATION_PRODUCTintravenous 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.
Sponsors
Hematology department of the 920th hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
DSA positive, receive HSCT in our hospital. -
Exclusion criteria
Have alternative DSA-negative donor, expended life-span less than 1 month. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| acute graft-versus-host disease rate | 2 years | the incidence of patients who developed aGVHD |
| chronic graft-versus-host disease rate | 2 years | the incidence of patients who developed cGVHD |
| poor graft function rate | 2 years | Number of patients who have \>95% donor chinerism but blood morphology does not return. |
| overall survival | 2 years | — |
| disease free survival | 2 years | — |
| nonrelapse mortality | 2 years | — |
Countries
China
Outcome results
None listed