Preventing the bone marrow graft from attacking the host's organs by injection of regulatory cells.

• Conditions: Steroid-refractory chronic graft-versus-host-disease.; MedDRA version: 16.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2012-000301-71-BE
• Lead Sponsor: CHU-ULg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-06
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

•Signed informed consent.
•Grafts from HLA-identical siblings or HLA-matched unrelated donor (1 of 10 HLA-mismatch is allowed).
•= 18 years of age.
•Steroid-refractory or steroid-resistant chronic GVHD defined as:
-development of 1 or more new sites of disease while being treated for chronic GVHD,
-progression of existing sites of disease while receiving treatment for chronic GVHD,
-failure to improve despite at least 1 month of standard treatment for chronic GVHD.
•Severe chronic GVHD and contra-indication to the use of steroids.
•GFR > 25 mL/min.
•No alemtuzumab administration in the last 6 years.
•Karnofsky performance score = 70%.
•DLCO > 35% and no need of supplemental continuous oxygen.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•Prior failure of rapamycine as treatment for chronic GVHD
•Contra-indication to the use of rapamycin.
•HIV seropositivity.
•Fungal infection with radiological progression after treatment
•Other uncontrolled infection.
•Progression of the hematological malignancy.
•Active post-transplant microangiopathy or previous microangiopathy while on rapamycine.
•Uncontrolled hypertriglyceridemia

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical and immunological impact of donor Treg infusion (DTI) in patients with steroid-refractory chronic GVHD<br><br>;Secondary Objective: ;Primary end point(s): To assess the safety of a combination of donor Treg infusion and rapamycine administration in patients with steroid-refractory chronic GVHD.<br><br>;Timepoint(s) of evaluation of this end point: Monitoring throughout the whole trial