Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD
- Registration Number
- NCT02848105
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VPA+Methyl VPA VPA added to standard methylpredisonlone treatment for aGVHD
- Primary Outcome Measures
Name Time Method complete response 28 days after the treatment
- Secondary Outcome Measures
Name Time Method Overall response (complete + partial response) 28 days after the treatment
Trial Locations
- Locations (1)
Blood & Marrow Transplantation Center, RuiJin Hospital
🇨🇳Shanghai, Shanghai, China