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

Not Applicable

Completed

• Conditions: Leukemia
• Interventions: Drug: low-dose glucocorticoid Methylprednisolone

• Registration Number: NCT01607580
• Lead Sponsor: Peking University People's Hospital

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

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 Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Study Start: 2012-06
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• no severe diarrhea no serious infection

Exclusion Criteria

• serious diarrhea active,uncontrolled infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no intervention after transplant	low-dose glucocorticoid Methylprednisolone	-
low-dose glucocorticoid	low-dose glucocorticoid Methylprednisolone	drug

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital，Institute of Hematology; 🇨🇳 Beijing, China