aGVHD, Peripheral Blood Stem Cell Transplantation
Conditions
Keywords
aGVHD, valproic acid
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.
Interventions
DRUGVPA
Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response | 28 days after the treatment |
Secondary
| Measure | Time frame |
|---|---|
| Overall response (complete + partial response) | 28 days after the treatment |
Countries
China
Contacts
Primary ContactJiong HU, M.D.,
Backup ContactLing Wang, M.D.,
Outcome results
None listed