NCT02848105

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

July 26, 2016

Last Update Submit

July 29, 2016

Conditions

Peripheral Blood Stem Cell TransplantationaGVHD

Keywords

aGVHDvalproic acid

Outcome Measures

Primary Outcomes (1)

  • complete response

    28 days after the treatment

Secondary Outcomes (1)

  • Overall response (complete + partial response)

    28 days after the treatment

Study Arms (1)

VPA+Methyl

EXPERIMENTAL

VPA added to standard methylpredisonlone treatment for aGVHD

Drug: VPA

Interventions

VPADRUG

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

VPA+Methyl

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Grade II-IV aGVHD
  • No previous history of allergy to valproic acid
  • No active and severe infection

You may not qualify if:

  • GVHD Prophylaxis with valproic acid
  • severe organ dysfunction: heart, lung, liver and kidney

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

  • Jiong HU, M.D.,

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong HU, M.D.,

CONTACT

hujiong@medmail.com.cn

Ling Wang, M.D.,

CONTACT

cclingjar@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood and Marrow Transplantation Program

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

CN(1)