Overview

This trial is active, not recruiting.

Condition leukemia
Treatment low-dose glucocorticoid methylprednisolone
Sponsor Peking University People's Hospital
Start date June 2012
End date November 2013
Trial size 145 participants
Trial identifier NCT01607580, PUPH IRB [2012] (26)

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
drug
low-dose glucocorticoid methylprednisolone Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
(Other)
low-dose glucocorticoid methylprednisolone Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant

Primary Outcomes

Measure
incidence of acute graft-versus-host disease
time frame: paticipants will be followed for the duration of hospital stay,an expected average of 100 days

Secondary Outcomes

Measure
incidence of infection
time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days

Eligibility Criteria

Male or female participants up to 60 years old.

Inclusion Criteria: - no severe diarrhea no serious infection Exclusion Criteria: - serious diarrhea active,uncontrolled infection

Additional Information

Official title Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation——a Randomized, Controlled, Clinical Trial
Description patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Peking University People's Hospital.