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Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

Peripheral Blood Stem Cell Transplantation Clinical Trial

Official title:
Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation

Clinical Trial Summary

aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

Clinical Trial Description

To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • aGVHD
  • Peripheral Blood Stem Cell Transplantation
Clinical Trial Details
NCT number NCT02848105
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact Jiong HU, M.D.,
Email hujiong@medmail.com.cn
Status Recruiting
Phase Phase 2
Start date July 2016
Completion date December 2019
View Details
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