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Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation
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.
To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China
Start Date
July 1, 2016
Primary Completion Date
July 1, 2019
Completion Date
December 1, 2019
Last Updated
August 1, 2016
55
ESTIMATED participants
VPA
DRUG
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
NCT05436418
NCT07440654
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