stamceltransplantatie gerelateerde complicatie: Graft versus Host ziekte Graft versus Host Disease
Conditions
Interventions
Patients are randomized for treatment with 
-high dose prednisolone 2 mg/kg/day i.v. and placebo
-high dose prednisolone 2 mg/kg/day i.v. and MSC at day 1, day 8, and Day 22 
i.v.
Cyclosporine A + Mycophenolate prevention regimens will be (re)started or 
continued according to prevention schedule (Cyclosporine A through levels 
0.20-0,35 mmol/l).
Sponsors
HOVON
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Any age; - Previously treated with allo-SCT/ DLI; - Acute GVHD grade II iIV nvolving gut and/or liver, - WHO performance 0-3 ; - Negative pregnancy test (if applicable); - Patients must be willing and capable to use adequate contraception during therapy ; - Written Informed Consent by the patient and/or parent(s) or legal guardian(s);
Exclusion criteria
Exclusion criteria: - Patients with active, uncontrolled infection; - Rapid progressive hematological malignancy; - Patients pre-treated with prednisolone > 1 mg/kg for GVHD, for more than 72 hours prior to randomization/application of MSC/placebo; - Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) - Any psychological, familial, sociological and/or geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Known uncontrolled toxicity for DMSO;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary - Proportion of patients in each treatment arm who experience a CR-GVHD or PR-GVHD at day 57, without treatment failure (initiation of secondary treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary - Proportion of patients in each treatment arm who experience a CR-GVHD or PR-GVHD at dindicated timepoints (until 2 years), without treatment failure (initiation of secondary treatment) - Time to CR-GVHD or PR-GVHD - Amount of immune suppression at indicated days - Adverse events - 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) - The immunological genotype of responders and non-responders as well as donors in both groups (see Appendix E and F) - Quality of life - Cost-effectiveness - Relapse of the underlying disease (e.g. hematological malignancy) - Progression-free survival - Incidence and severity of chronic GVHD - Overall survival | — |
Countries
Netherlands
Outcome results
None listed