Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with
 steroid-refractory or dependent chronic graft vs host disease.

 Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks.
 Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell
 depletion and Regulatory T-cell Expansion)
Inclusion Criteria: (Main)

 -  1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH)
 Consensus with no more than 24 weeks of treatment with systemic steroids.

 AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of
 the following):

 -  Progression on prednisone 7 mg/kg/week for 2 weeks, or

 -  Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or

 -  Inability to taper prednisone below 3.5 mg/kg/week.

 Exclusion Criteria: (Main)

 -  1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.

 OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.

 OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks
 prior to enrollment.

 OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L
 on two last consecutive CBCs before inclusion