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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01589549




Registration number
NCT01589549
Ethics application status
Date submitted
26/04/2012
Date registered
2/05/2012
Date last updated
9/06/2015

Titles & IDs
Public title
Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
Scientific 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
Secondary ID [1] 0 0
CTN 2012/0174
Secondary ID [2] 0 0
2011/128
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute GVH Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Mesenchymal stromal cell therapy

Experimental: Mesenchymal stromal cell therapy - Mesenchymal stromal cell therapy in addition to corticosteroid therapy

Active Comparator: Corticosteroid therapy -


Other interventions: Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival at one year after onset of graft versus host disease
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Response at 14 days after commencement of treatment for acute graft versus host disease
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Response at 28 days after commencement of treatment of acute graft versus host disease
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Incidence of severe infection
Timepoint [3] 0 0
One year
Secondary outcome [4] 0 0
Disease free survival at one year
Timepoint [4] 0 0
One year
Secondary outcome [5] 0 0
Time to treatment failure, requiring salvage therapy
Timepoint [5] 0 0
28 days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Failure to sign informed consent

- Corticosteroid therapy for 72 hours or greater

- ECOG score equal to or greater than 3

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
R.P.Herrmann
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01589549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Duncan Purtill, MB, BS
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Duncan Purtill, MB, BS
Address 0 0
Country 0 0
Phone 0 0
+61 8 61523788
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01589549