Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 2

Conditions: aGVHD; Peripheral Blood Stem Cell Transplantation

Treatments: Drug: VPA

Study type: Interventional

Funder types: Other

Identifiers

NCT02848105

RJH-aGVHD-2016

Details and patient eligibility

About

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.

Full description

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

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

VPA+Methyl

Experimental group

Description:

VPA added to standard methylpredisonlone treatment for aGVHD

Treatment:

Drug: VPA