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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607580
• Other study ID #: PUPH IRB [2012] (26)
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• no severe diarrhea no serious infection

Exclusion Criteria:

• serious diarrhea active,uncontrolled infection

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Peking University People's Hospital,Institute of Hematology	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	engrafment	numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days	participants will be followed for the duration of hospital stay,an expected average of 100 days
Primary	incidence of acute graft-versus-host disease	number of participants with acute graft-versus-host disease at 100 days	paticipants will be followed for the duration of hospital stay,an expected average of 100 days
Secondary	incidence of infection	number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days	participants will be followed for the duration of hospital stay,an expected average of 100 days

External Links

•   hospital website