Table 1.
Patient characteristics.
Type of disease | Conditioning/ GVHD prophylaxis | Stem cell source and characteristics (HLA match) | Donor gender and age | aGVHD | cGVHD organ manifestations at the time of Treg infusion | Discontinued GVHD treatments prior to Treg infusion | GVHD treatment at the time of Treg infusion | |
---|---|---|---|---|---|---|---|---|
Patient 1 male 54 years | B‐CLL | Flu, Bu8/CSA, MTX | BM allo unrelated (10/10) | Male, 39 years | Skin II° | Severe skin III° (progressive, maculopapular rash); oral cavity III° (progressive, ulcerations); eyes II° (stable, keratoconjunctivitis sicca) | Tacro, MMF, Alemtu, Rituxi, Dacli, Evero, ECP, MSC | Prednisolone (10 mg/d) |
Patient 2 female 45 yrs | AML | Flu, 8 Gy TBI/CSA mono | PBSC allo related (10/10) | Female, 51 years | No | Severe skin III° (stable, ulcerations, sclerotic features); oral cavity II° (stable) | Tacro, MMF, ECP, MSC | Prednisolone (7.5 mg/d) Everolimus |
Alemtu = alemtuzumab (3 × 10 mg subcutaneously per week); AML = acute myeloid leukaemia; B‐CLL = B cell chronic lymphocytic leukaemia; BM = bone marrow; Bu = busulfan, Bu8 (8 mg/kg per os total); CSA = cyclosporin; cyclophosphamide (120 mg/kg total); Dacli = daclizumab (1 mg/kg); ECP = extracorporeal photopheresis; Evero = everolimus; Flu = fludarabine (30 mg/m2/day for 5 days); MTX = methotrexate [graft‐versus‐host disease (GVHD) prophylaxis: cumulative dose 45 mg/m2, days 1, 3, 6, 11 after haematopoietic stem cell (HCT); GVHD treatment: 5 mg/m2 per week]; MMF = mycophenolate mofetil; MSC = mesenchymal stromal cells [average dose 1 × 106/kg body weight intravenously (i.v.)]; Rituxi = rituximab (100 mg i.v. per week); Tacro = tacrolimus; TBI = hyperfractionated total body irradiation (dose in Gy); HLA = human leucocyte antigen.