Main info

Identificatie:

HO112 MSC

Sponsor:

HOVON

Working group party:

SCT & Supportive care

Age:

Any age

Stadium:

1st lijn

Echelon:

Level A

Included patients:

39

(of 200)

Active sites:

2

(of 12)

Title:

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

Timeline

News

Flow

Details

Phase:

Prospective double-blind randomized phase III study

Monitoring Type:

Site Evaluation Visit

Objectives:

• To improve the response rate to treatment of grade II-IV acute GVHD involving gut and/or liver by adding MSC to standard high dose prednisolone
• To study the safety of the addition of MSC to standard treatment of severe acute GVHD as compared to standard treatment alone
• To study quality of life
• To study cost-effectiveness
• To study the (immunological) phenotype before and after application of MSC/placebo of responders and non-responders in both groups at different sites (see protocol Appendix E and F)
• To study the immunological genotype of responders and non-responders as well as donors in both groups (see protocol Appendix E and F)
• To study the incidence of relapse of the underlying disease (e.g. hematological malignancy)
• To study progression free survival (of the underlying disease)
• To study overall survival

Eligibility

Inclusion Criteria:

• Any age;
• Previously treated with allo-SCT/ DLI;
• Grade II-IV acute GVHD involving gut and/or liver according to protocol appendix A (confirmed by histology of involved tissues, however, the first infusion of MSC/placebo can be given without final histological confirmation);
• WHO performance 0-3;
• Negative pregnancy test (if applicable);
• Patients must be willing and capable to use adequate contraception during therapy (if applicable) ;
• Written Informed Consent by the patient and/or parent(s) or legal guardian(s).

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;
• Known uncontrolled toxicity for DMSO;
• 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.

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals