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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607580 on ClinicalTrials.gov