Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02848105
Other study ID # RJH-aGVHD-2016
Secondary ID
Status Recruiting
Phase Phase 2
First received July 26, 2016
Last updated July 29, 2016
Start date July 2016
Est. completion date December 2019

Study information

Verified date July 2016
Source Shanghai Jiao Tong University School of Medicine
Contact Jiong HU, M.D.,
Email hujiong@medmail.com.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • aGVHD
  • Peripheral Blood Stem Cell Transplantation

Intervention

Drug:
VPA
Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml

Locations

Country Name City State
China Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04582604 - Ruxolitinib and Decitabine for High Risk Hematological Malignancies Phase 1/Phase 2
Recruiting NCT05436418 - The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation Phase 1/Phase 2
Recruiting NCT05075681 - Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Phase 1/Phase 2
Completed NCT03993639 - KRN125 for Mobilization of Hematopoietic Stem Cells Phase 2
Completed NCT02398708 - Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT
Completed NCT00575809 - Incidence and Factors Associated With the Development and Severity of Oral Mucositis
Completed NCT00670423 - A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Phase 1
Terminated NCT02326675 - Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant N/A
Recruiting NCT05153226 - GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG Phase 3
Not yet recruiting NCT03771222 - Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies Phase 2
Completed NCT02512679 - Related Hematopoietic Stem Cell Transplantation (HSCT) for Genetic Diseases of Blood Cells Phase 2
Recruiting NCT05088226 - Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen Phase 2
Recruiting NCT05961410 - Eltrombopag for Peripheral Blood Stem Cell Harvest Phase 2