Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)

Sponsor

Peking University People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01607580

Collaborator

(none)

145

Enrollment

Locations

Arms

Duration (Months)

72.5

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: low-dose glucocorticoid Methylprednisolone	N/A

Detailed Description

patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low-dose glucocorticoid drug	Drug: low-dose glucocorticoid Methylprednisolone patients receive low-dose glucocorticoid from day 5 post transplant Other Names: Methylprednisolone
Other: no intervention after transplant	Drug: low-dose glucocorticoid Methylprednisolone patients receive low-dose glucocorticoid from day 5 post transplant Other Names: Methylprednisolone

Arm

Intervention/Treatment

Experimental: low-dose glucocorticoid

drug

Drug: low-dose glucocorticoid Methylprednisolone

patients receive low-dose glucocorticoid from day 5 post transplant

Other Names:

Methylprednisolone

Other: no intervention after transplant

Drug: low-dose glucocorticoid Methylprednisolone

patients receive low-dose glucocorticoid from day 5 post transplant

Other Names:

Methylprednisolone

Outcome Measures

Primary Outcome Measures

incidence of acute graft-versus-host disease [paticipants will be followed for the duration of hospital stay,an expected average of 100 days]
number of participants with acute graft-versus-host disease at 100 days

Secondary Outcome Measures

incidence of infection [participants will be followed for the duration of hospital stay,an expected average of 100 days]
number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days

Other Outcome Measures

engrafment [participants will be followed for the duration of hospital stay,an expected average of 100 days]
numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days