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

NCT01607580 | Completed DMC

• 1 other identifier: PUPH IRB [2012] (26)
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

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

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of infection

  participants will be followed for the duration of hospital stay,an expected average of 100 days

Other Outcomes (1)

• engrafment

  participants will be followed for the duration of hospital stay,an expected average of 100 days

Study Arms (2)

low-dose glucocorticoid

EXPERIMENTAL

drug

Drug: low-dose glucocorticoid Methylprednisolone

no intervention after transplant

OTHER

Drug: low-dose glucocorticoid Methylprednisolone

Interventions

low-dose glucocorticoid Methylprednisolone DRUG

patients receive low-dose glucocorticoid from day 5 post transplant

Also known as: Methylprednisolone

low-dose glucocorticoid; no intervention after transplant

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• no severe diarrhea no serious infection

You may not qualify if:

• serious diarrhea active,uncontrolled infection

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (2)

Peking University People's Hospital，Institute of Hematology

Beijing, 100044, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (1)

• Chang YJ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Tang FF, Mo XD, Liu KY, Huang XJ. Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graft-versus-Host Disease and Graft-versus-Host Disease-Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial. Biol Blood Marrow Transplant. 2019 Mar;25(3):529-537. doi: 10.1016/j.bbmt.2018.11.020. Epub 2018 Nov 24.

  PMID: 30481596 DERIVED

Related Links

• hospital website

MeSH Terms

Conditions

Leukemia

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Peking University People's Hospital，Institute of Hematology

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

CN (2)