Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.A phase III randomized double-blind multi-center HOVON study.
- Conditions
- graft-versus-host disease, steroid-refractory
- Registration Number
- NL-OMON27391
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
•Grade II-IV acute GvHD with gut and/or liver involvement, confirmed by histology of involved tissues (in case of gut and liver involvement histology of either one of these tissues is considered sufficient);
• Non-responsive to treatment with steroids and a calcineurin-inhibitor defined as:
Exclusion Criteria
•Use of prophylactic MMF, Myfortic or other systemic treatment for acute GvHD ≤ 6 days prior to development of acute GvHD grade II-IV with gut and/or liver involvement;
•Systemic treatment for acute GvHD other than steroids and a calcineurin inhibitor (budesonide is considered a local treatment);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients responding to treatment of acute GvHD grade II-IV (with gut and/or liver involvement) at day 29. <br><br><br>
- Secondary Outcome Measures
Name Time Method 1.Overall survival<br /><br>2.Progression-free survival<br /><br>3.Duration of acute GvHD response<br /><br>4.Time without systemic immunosuppression <br /><br>5.Cumulative incidents of non-relapse mortality<br /><br>6.Adverse events<br /><br>7.Incidence of chronic GvHD<br /><br>8.Quality of life <br /><br>9.Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of acute GvHD