Acute GVH DiseasePhase 2NCT01589549
Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
A Phase 2 study testing Mesenchymal stromal cell therapy in people with Acute GVH Disease, run by R.P.Herrmann at 1 site in Australia.
Trial summary
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy. It is hypothesised that mesenchymal stromal cell therapy will be superior Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute GVH Disease
- What is being tested?
- Mesenchymal stromal cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Dec 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
- Age 18-55 years
- Must be receiving a calcineurin inhibitor
Who cannot join
- Failure to sign informed consent
- Corticosteroid therapy for 72 hours or greater
- ECOG score equal to or greater than 3
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Megan Margaria, BN, +61 8 92247038, megan.margaria@health.wa.gov.au
About this study
Official title: A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.
It is hypothesised that mesenchymal stromal cell therapy will be superior
Read the detailed description
Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals
- Conditions
- Acute GVH Disease
- Being tested
- Mesenchymal stromal cell therapy
- Keywords
- Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stromal cell therapyBiological
Also called Methylprednisolone, Mesenchymal stem cells
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stromal cell therapy | Experimental | Mesenchymal stromal cell therapy in addition to corticosteroid therapy Receives: Biological: Mesenchymal stromal cell therapy |
| Corticosteroid therapy | Active comparator | Not described Receives: Biological: Mesenchymal stromal cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at one year after onset of graft versus host disease
Measured: One year
Secondary outcomes (5)
Response at 14 days after commencement of treatment for acute graft versus host disease
Measured: 14 days
Response at 28 days after commencement of treatment of acute graft versus host disease
Measured: 28 days
Incidence of severe infection
Measured: One year
Disease free survival at one year
Measured: One year
Time to treatment failure, requiring salvage therapy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GVH DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R.P.Herrmann
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital
- Responsible party
- Sponsor-investigator, R.P.Herrmann, Royal Perth Hospital
- Investigators
- Duncan Purtill, MB, BS, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589549
- Sponsor's protocol ID
- 2011/128
- Other IDs
- CTN 2012/0174
- Status last verified
- Jun 2015
- First submitted
- 26 Apr 2012
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT01589549
- Acronym / sponsor ID
- 2011/128
- Conditions
- Acute GVH Disease
- Keywords
- Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- R.P.HerrmannUniversity, hospital or other
- Collaborators
- Royal Perth Hospital
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 May 2012 (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.
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.
It is hypothesised that mesenchymal stromal cell therapy will be superior
Detailed description
Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stromal cell therapy | Experimental | Biological: Mesenchymal stromal cell therapyMesenchymal stromal cell therapy in addition to corticosteroid therapy |
| Corticosteroid therapy | Active comparator | Biological: Mesenchymal stromal cell therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
- Age 18-55 years
Key exclusion criteria (3 listed)
- Failure to sign informed consent
- Corticosteroid therapy for 72 hours or greater
- ECOG score equal to or greater than 3
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 |
|---|---|---|
| Mesenchymal stromal cell therapyAlso: Methylprednisolone, Mesenchymal stem cellsOne arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy | Biological | Corticosteroid therapy, Mesenchymal stromal cell therapy |
Primary outcome
Survival at one year after onset of graft versus host disease
Time frame: One year
5 secondary outcomes
Response at 14 days after commencement of treatment for acute graft versus host disease
Time frame: 14 days
Response at 28 days after commencement of treatment of acute graft versus host disease
Time frame: 28 days
Incidence of severe infection
Time frame: One year
Disease free survival at one year
Time frame: One year
Time to treatment failure, requiring salvage therapy
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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.
Duncan Purtill, MB, BS principal investigator
Royal Perth Hospital
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 Mesenchymal stromal cell therapy in people with Acute GVH Disease, run by R.P.Herrmann at 1 site in Australia.
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 3 inclusion and 3 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 9 Jun 2015. 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 Australia. 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 Duncan Purtill, MB, BS (+61 8 61523788, duncan.purtill@health.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at one year after onset of graft versus host disease (time frame: One year). 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 9 Jun 2015.