Peripheral Blood Stem Cell TransplantationPhase 2NCT02848105
Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD
A Phase 2 study testing VPA in people with Peripheral Blood Stem Cell Transplantation and aGVHD, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peripheral Blood Stem Cell Transplantation, aGVHD
- What is being tested?
- VPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grade II-IV aGVHD
- No previous history of allergy to valproic acid
- No active and severe infection
- GVHD Prophylaxis with valproic acid
- severe organ dysfunction: heart, lung, liver and kidney
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Jiong HU, M.D., contact
Ling Wang, M.D., contact
China1 site, 1 recruiting
- Recruiting
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, 200025
Jiong HU, M.D.,, 86-21-64370045, hujiong@medmail.com.cn
Ling Wang, M.D.,, 86-21-64370045, cclingjar@163.com
About this study
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
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.
Read the detailed description
To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.
- Conditions
- Peripheral Blood Stem Cell Transplantation, aGVHD
- Being tested
- VPA
- Keywords
- aGVHD, valproic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPADrug
Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml
| Study group | Role | What they receive |
|---|---|---|
| VPA+Methyl | Experimental | VPA added to standard methylpredisonlone treatment for aGVHD Receives: Drug: VPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
Measured: 28 days after the treatment
Secondary outcomes (1)
Overall response (complete + partial response)
Measured: 28 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Blood Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong HU, M.D.,, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848105
- Sponsor's protocol ID
- RJH-aGVHD-2016
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02848105
- Acronym / sponsor ID
- RJH-aGVHD-2016
- Conditions
- Peripheral Blood Stem Cell Transplantation, aGVHD
- Keywords
- aGVHD, valproic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPA+Methyl | Experimental | Drug: VPAVPA added to standard methylpredisonlone treatment for aGVHD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Grade II-IV aGVHD
- No previous history of allergy to valproic acid
- No active and severe infection
- GVHD Prophylaxis with valproic acid
- severe organ dysfunction: heart, lung, liver and kidney
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPAValproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml | Drug | VPA+Methyl |
Primary outcome
complete response
Time frame: 28 days after the treatment
1 secondary outcome
Overall response (complete + partial response)
Time frame: 28 days after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiong HU, M.D., contact
Ling Wang, M.D., contact
Jiong HU, M.D., principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VPA in people with Peripheral Blood Stem Cell Transplantation and aGVHD, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiong HU, M.D., (hujiong@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: 28 days after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.