Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

NCT ID: NCT02848105

Last Updated: 2016-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

Brief Summary

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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

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

Conditions

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Peripheral Blood Stem Cell Transplantation aGVHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VPA+Methyl

VPA added to standard methylpredisonlone treatment for aGVHD

Group Type EXPERIMENTAL

VPA

Intervention Type DRUG

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

Interventions

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VPA

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head, Blood and Marrow Transplantation Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiong HU, M.D.,

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiong HU, M.D.,

Role: CONTACT

Ling Wang, M.D.,

Role: CONTACT

Facility Contacts

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Jiong HU, M.D.,

Role: primary

86-21-64370045

Ling Wang, M.D.,

Role: backup

86-21-64370045

Other Identifiers

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RJH-aGVHD-2016

Identifier Type: -

Identifier Source: org_study_id

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