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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01607580

Enrollment

145

Registered

2012-05-30

Start date

2012-06-30

Completion date

2014-02-28

Last updated

2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

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).

Interventions

DRUGlow-dose glucocorticoid Methylprednisolone

patients receive low-dose glucocorticoid from day 5 post transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 60 Years

Healthy volunteers

Inclusion criteria

* no severe diarrhea no serious infection

Exclusion criteria

* serious diarrhea active,uncontrolled infection

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026