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

Peking University

Status: Completed

Conditions: Leukemia

Treatments: Drug: low-dose glucocorticoid Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01607580

PUPH IRB [2012] (26)

Details and patient eligibility

About

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

Full description

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

Enrollment: 145 patients

Sex: All

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• no severe diarrhea no serious infection

Exclusion criteria

• serious diarrhea active,uncontrolled infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

low-dose glucocorticoid

Experimental group

Description:

drug

Treatment:

Drug: low-dose glucocorticoid Methylprednisolone

no intervention after transplant

Other group

Treatment:

Drug: low-dose glucocorticoid Methylprednisolone