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Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

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ClinicalTrials.gov Identifier: NCT02848105
Recruitment Status : Unknown
Verified July 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 28, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Jiong HU, 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.

Condition or disease Intervention/treatment Phase
Peripheral Blood Stem Cell Transplantation aGVHD Drug: VPA Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: VPA+Methyl
VPA added to standard methylpredisonlone treatment for aGVHD
Drug: VPA
Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml




Primary Outcome Measures :
  1. complete response [ Time Frame: 28 days after the treatment ]

Secondary Outcome Measures :
  1. Overall response (complete + partial response) [ Time Frame: 28 days after the treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848105


Contacts
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Contact: Jiong HU, M.D., hujiong@medmail.com.cn
Contact: Ling Wang, M.D., cclingjar@163.com

Locations
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China, Shanghai
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Jiong HU, M.D.,    86-21-64370045    hujiong@medmail.com.cn   
Contact: Ling Wang, M.D.,    86-21-64370045    cclingjar@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jiong HU, M.D., Shanghai Jiao Tong University School of Medicine

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Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Program, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02848105    
Other Study ID Numbers: RJH-aGVHD-2016
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
aGVHD
valproic acid
Additional relevant MeSH terms:
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Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs