Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborator: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Grade II-IV aGVHD

• No previous history of allergy to valproic acid

• No active and severe infection

Exclusion Criteria:

• Inclusion in other clinical trial

• GVHD Prophylaxis with valproic acid

• severe organ dysfunction: heart, lung, liver and kidney