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| ID | Type | Description | Link |
|---|---|---|---|
| 202301AY070001-226 | Other Grant/Funding Number | the Joint and Special Project of Kunming medical university |
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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion | Combination Product | patients received intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion for decresing donor specific antibodies. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft failure Rate | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| poor graft function rate | Number of patients who have >95% donor chinerism but blood morphology does not return. | 2 years |
| acute graft-versus-host disease rate | the incidence of patients who developed aGVHD |
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Inclusion Criteria: DSA positive, receive HSCT in our hospital. -
Exclusion Criteria: Have alternative DSA-negative donor, expended life-span less than 1 month.
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Patients who received haplo-HSCT and had donor specific antibodies at our hospital were enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, Professor | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 2 years |
| chronic graft-versus-host disease rate | the incidence of patients who developed cGVHD | 2 years |
| nonrelapse mortality | 2 years |
| overall survival | 2 years |
| disease free survival | 2 years |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |