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

• Conditions: Graft Versus Host Disease; MedDRA version: 18.0Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 18.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-003237-33-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-15
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

-Any age;
-Previously treated with allo-SCT/ DLI;
-Grade II-IV acute GVHD involving gut and/or liver, confirmed by histology of involved tissues, however, the first infusion of MSC 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);

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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;
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified