NCT02848105

Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Peripheral Blood Stem Cell Transplantation
• aGVHD

Interventions

Type	Name	Description
DRUG	VPA	Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2016-07-28
• Last updated: 2016-08-01

Locations

1 site across 1 country: China