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

September 23, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital，Institute of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no severe diarrhea no serious infection

Exclusion Criteria:

  • serious diarrhea active,uncontrolled infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-dose glucocorticoid
drug
Drug: low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
Other Names:
  • Methylprednisolone
Other: no intervention after transplant
Drug: low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
Other Names:
  • Methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of infection
Time Frame: 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
participants will be followed for the duration of hospital stay,an expected average of 100 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
engrafment
Time Frame: 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
participants will be followed for the duration of hospital stay,an expected average of 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUPH IRB [2012] (26)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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