Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)
NCT01607580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2020-09-24
Summary
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
Conditions
Interventions
- DRUG
-
low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
Sponsors & Collaborators
-
Peking University People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2013-11-30
- Completion
- 2014-02-28
Countries
- China
Study Locations
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