Status:
TERMINATED
Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)
Lead Sponsor:
University of Liege
Conditions:
Chronic Graft-Versus-Host Disease
Acute Graft-Versus-Host Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus ...
Detailed Description
TREATMENT PLAN 1 Immunosuppressive drugs (DTI and control arms) * Rapa will be started within 2 weeks after inclusion. Rapa will be given at 2-6 mg loading dose for one day, followed by approximatel...
Eligibility Criteria
Inclusion
- 1\. Patient criteria : Donor Treg infusion (DTI) and control arms.
- 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.
- or severe chronic GVHD and contra-indication to the use of steroids and at least failed one prior line of treatment.
- Severe chronic GVHD according to NIH definition.
- No prior failure of rapamycine as treatment for chronic GVHD
- No contra-indication to the use of rapamycin.
- No alemtuzumab administration in the last 6 months.
- GFR \> 25 mL/min.
- No HIV seropositivity.
- No fungal infection with radiological progression after treatment with amphotericine B or active azoles for \> 1 month.
- No other uncontrolled infection.
- No progression of the hematological malignancy.
- Karnofsky performance score ≥ 70%.
- DLCO \> 35% and no need of supplemental continuous oxygen.
- No active post-transplant microangiopathy and no previous microangiopathy while on rapamycine.
- No uncontrolled hypertriglyceridemia.
- 2 Donor criteria : DTI arm only.
- Donor ≥ 18 years of age.
- Written informed consent to perform apheresis from the donor (all patients) and permission from the third party donor registry (in case of unrelated donor).
- Standard criteria for leukapheresis and DLI following complete work-up according to standard procedures.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01903473
Start Date
July 1 2013
End Date
September 12 2022
Last Update
September 22 2022
Active Locations (2)
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1
Katholieke Universiteit Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
2
University Hospital Liège
Liège, Belgium, 4000