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Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.
It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).
The study hypothesis:
Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD
patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose glucocorticoid | Experimental | drug |
|
| no intervention after transplant | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose glucocorticoid Methylprednisolone | Drug | patients receive low-dose glucocorticoid from day 5 post transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of acute graft-versus-host disease | number of participants with acute graft-versus-host disease at 100 days | paticipants will be followed for the duration of hospital stay,an expected average of 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of infection | number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days | participants will be followed for the duration of hospital stay,an expected average of 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| engrafment | numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days | participants will be followed for the duration of hospital stay,an expected average of 100 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital，Institute of Hematology | Beijing | 100044 | China | |||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30481596 | Derived | Chang YJ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Tang FF, Mo XD, Liu KY, Huang XJ. Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graft-versus-Host Disease and Graft-versus-Host Disease-Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial. Biol Blood Marrow Transplant. 2019 Mar;25(3):529-537. doi: 10.1016/j.bbmt.2018.11.020. Epub 2018 Nov 24. |
| Label | URL |
|---|---|
| hospital website | View source |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| Beijing |
| 100044 |
| China |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |