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Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

S

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)

55 participants in 1 patient group

VPA+Methyl
Experimental group
Description:
VPA added to standard methylpredisonlone treatment for aGVHD
Treatment:
Drug: VPA

Trial contacts and locations

1

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Central trial contact

Ling Wang, M.D.,; Jiong HU, M.D.,

Data sourced from clinicaltrials.gov

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