Table 2.
Study ID | Dose level; # doses | Time from GVHD dx (days) | Max grade; stage1 | Treatment on day 1 | Other treatments | Timepoint | Grade | Stage | Overall response | Steroid dose (mg/kg) |
---|---|---|---|---|---|---|---|---|---|---|
EPIC2014-012 | 1; 1 | 129 | II; 3/0/0/0 | Steroid, FK, ECP | ATG | D1 | II | 2/0/0/0 | CR | 0.7→03 |
D8 | I | 1/0/0/0 | ||||||||
D15 | I | 1/0/0/0 | ||||||||
D29 | I | 1/0/0/0 | ||||||||
D36 | I | 1/0/0/0 | ||||||||
3 months | II | 3/0/0/0 | ||||||||
6 months | 0 | 0/0/0/0 | ||||||||
EPIC2014-05 | 1; 1 | 77 | IV; 0/1/4/0 | Steroid, FK, ruxolitinib, ECP | ATG, MMF, infliximab | D1 | IV | 0/1/4/0 | MR | 0.9→0.6 |
D8 | IV | 0/1/4/0 | ||||||||
D15 | II | 0/0/1/0 | ||||||||
D29 | IV | 0/0/4/0 | ||||||||
D36 | I | 0/1/0/0 | ||||||||
D42 | IV | 0/1/4/0 | ||||||||
2 months | I | 0/1/0/0 | ||||||||
3 months | III | 0/0/0/3 | ||||||||
EPIC2014-064 | 1; 1 | 146 | IV; 0/1/4/0 | Steroid, FK | Sirolimus, MMF, ECP | D1 | IV | 0/0/4/0 | NR | 1.1→0.7 |
D8 | IV | 0/1/4/0 | ||||||||
D15 | IV | 0/0/4/0 | ||||||||
D29 | IV | 0/0/4/0 | ||||||||
D36 | IV | 0/1/4/0 | ||||||||
EPIC2014-15 | 3; 4 | 122 | III; 0/0/2/0 | Steroid, FK | Remicade, Jakafi | D1 | II | 0/0/1/0 | PR | 1.0→0 |
D8 | II | 0/0/1/0 | ||||||||
D15 | II | 0/0/1/0 | ||||||||
D29 | II | 0/0/1/0 | ||||||||
D36 | III | 0/0/2/0 | ||||||||
2 months | III | 0/0/2/0 | ||||||||
3 months | III | 0/0/2/0 | ||||||||
6 months | II | 0/0/1/0 | ||||||||
12 months | II | 0/0/1/0 |
GVHD, graft-versus-host disease; MSC, mesenchymal stromal cells; Max, maximum; FK, tacrolimus; ECP, extracorporeal photopheresis; ATG, anti-thymocyte globulin; MMF, mycophenolate mofetil; CR, complete response; NR, no response; PR, partial response; UGI, upper gastrointestinal; LGI, lower GI.
(1)Stage reported as skin/UGI/LGI/liver.
(2)Chronic GVHD diagnosed on 2/24/2015. Skin GVHD developed chronic features during the study.
(3)Steroids weaned off within a few days of first MSC infusion.
(4)Overlap GVHD with acute phenotype.