Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)
This trial is active, not recruiting.
|Treatment||low-dose glucocorticoid methylprednisolone|
|Sponsor||Peking University People's Hospital|
|Start date||June 2012|
|End date||November 2013|
|Trial size||145 participants|
|Trial identifier||NCT01607580, PUPH IRB  (26)|
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
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
incidence of acute graft-versus-host disease
time frame: paticipants will be followed for the duration of hospital stay,an expected average of 100 days
incidence of infection
time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days
Male or female participants up to 60 years old.
Inclusion Criteria: - no severe diarrhea no serious infection Exclusion Criteria: - serious diarrhea active,uncontrolled infection
|Official title||Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation——a Randomized, Controlled, Clinical Trial|
|Description||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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