EUCTR2012-000301-71-BEActive, not recruitingNot Applicable
Donor Regulatory T cells (Treg) infusion (DTI) in patients with steroid-refractory chronic graft-versus-host disease (GVHD).
CHU-ULg0 sites35 target enrollmentStarted: December 6, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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