Treatment of severe acute GVHD after allogeneic hematopoietic stem celltransplantation with steroids versus MSC and steroids.A prospective double-blind placebo-controlled randomized phase III trial
Recruiting
- Conditions
- graft-versus-host disease
- Registration Number
- NL-OMON29599
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Any age;
- Previously treated with allo-SCT/ DLI;
Exclusion Criteria
- Patients with active, uncontrolled infection;
- Rapid progressive hematological malignancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients in each treatment arm who experience a CRGVHD or PRGVHD (see Appendix B) at day 57, without treatment failure (initiation of secondary treatment,progression/relapse, or death)
- Secondary Outcome Measures
Name Time Method - Proportion of patients in each treatment arm who experience a CRGVHD or PRGVHD (see Appendix B) at other indicated days (see 10.2 until 2 years) after initiation of study-treatment, without treatment failure<br /><br>- Time to CRGVHD or PRGVHD<br /><br>- Amount of immune suppression at other indicated days (see 10.2 until 2 years)<br /><br>- Adverse events<br /><br>- The (immunological) phenotype before and after application of MSC/placebo of responders and non-responders in both groups at different sites (see Appendix E and F)<br /><br>- The immunological genotype of responders and non-responders as well as donors in both groups (see Appendix E and F)<br>- Quality of life<br /><br>- Cost-effectiveness<br /><br>- Relapse of the underlying disease (e.g. hematological malignancy)<br /><br>- Progression-free survival<br /><br>- Incidence and severity of chronic GVHD<br /><br>- Overall survival