Peripheral Blood Stem Cell Transplantation Clinical Trial
Official title:
Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation
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.
| Status | Recruiting |
| Enrollment | 55 |
| Est. completion date | December 2019 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Blood & Marrow Transplantation Center, RuiJin Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Jiao Tong University School of Medicine | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complete response | 28 days after the treatment | No | |
| Secondary | Overall response (complete + partial response) | 28 days after the treatment | No |
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