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Multiple Donor Regulatory T Cell (Treg) Infusions (T Reg DLI) for Severe Refractory Chronic Graft Versus Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (TREG2015001)
This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS. The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION. The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the following chapter. The primary objective of the dose escalation study will be SAFETY, leading to the definition of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL RESPONSE RATE at three months after the 3rd Treg infusion. The study is single center single arm open label and includes a DOSE ESCALATION phase followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD). The aim of the study is to assess whether multiple infusions of donor-derived purified T regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and whether it may induce clinical remission of GVHD.
Details
| Lead sponsor | Mario Arpinati |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2016-08-03 |
| Completion | 2022-06 |
Conditions
- Chronic Graft Versus Host Disease
Interventions
- T reg DLI
Primary outcomes
- OVERALL RESPONSE RATE — 3 months after last T reg infusion
The response of chronic GVHD to treatment will be assessed per NIH consensus criteria. Overall response will be defined as either a complete o partial response. Complete Response is defined as resolution of all reversible manifestations related to cGVHD in a specific organ. Partial Response will be defined as at least 50% improvement in the scale used to measure disease manifestations related to cGVHD (e.g. a 50% decrease in skin rash from 80% BSA to 40% BSA), in at least one organ or site, without progression in measures at any other organ or site.
Countries
Italy