Clinical characteristics of participants
| Clinical characteristics . | No. . |
|---|---|
| N | 34 |
| Age, median (range), y | 56 (22-73) |
| Sex, M/F | 21/13 |
| Diagnosis, no. | |
| AML | 7 |
| ALL | 7 |
| MDS | 7 |
| NHL | 5 |
| MPN | 3 |
| Multiple myeloma | 2 |
| Other* | 3 |
| Donor | |
| Matched unrelated | 18 |
| Matched related | 7 |
| Mismatched unrelated | 5 |
| Umbilical cord blood | 4 |
| Stem cell source | |
| Peripheral blood stem cells | 29 |
| Bone marrow | 1 |
| Umbilical cord blood | 4 |
| Conditioning regimen | |
| Myeloablative | 11 |
| Reduced intensity | 23 |
| GVHD prophylaxis | |
| Tacrolimus/MTX | 17 |
| Tacrolimus/sirolimus ± MTX | 3 |
| Tacrolimus/MTX/other† | 7 |
| Tacrolimus or cyclosporine/MMF | 5 |
| Ex vivo T-cell depletion | 2 |
| aGVHD grade at enrollment | |
| II | 10 |
| III | 22 |
| IV | 8 |
| Time from aGVHD onset to day 1 of BV, median (range) | 31 d (6-185) |
| Time from day 0 of HCT (or DLI) to day 1 of BV, median (range) | 88 d (28-371) |
| Category of SR-aGVHD | |
| Progressing or not improving on initial steroids | 25 |
| Flare upon steroid tapering | 9 |
| BV dose level | |
| 0.6 mg/kg IV weekly × 3 | 3 |
| 0.9 mg/kg IV weekly × 3 | 3 |
| 0.6 mg/kg IV every other week × 4 | 10 |
| 0.8 mg/kg IV every other week × 4 | 18 |
| Clinical characteristics . | No. . |
|---|---|
| N | 34 |
| Age, median (range), y | 56 (22-73) |
| Sex, M/F | 21/13 |
| Diagnosis, no. | |
| AML | 7 |
| ALL | 7 |
| MDS | 7 |
| NHL | 5 |
| MPN | 3 |
| Multiple myeloma | 2 |
| Other* | 3 |
| Donor | |
| Matched unrelated | 18 |
| Matched related | 7 |
| Mismatched unrelated | 5 |
| Umbilical cord blood | 4 |
| Stem cell source | |
| Peripheral blood stem cells | 29 |
| Bone marrow | 1 |
| Umbilical cord blood | 4 |
| Conditioning regimen | |
| Myeloablative | 11 |
| Reduced intensity | 23 |
| GVHD prophylaxis | |
| Tacrolimus/MTX | 17 |
| Tacrolimus/sirolimus ± MTX | 3 |
| Tacrolimus/MTX/other† | 7 |
| Tacrolimus or cyclosporine/MMF | 5 |
| Ex vivo T-cell depletion | 2 |
| aGVHD grade at enrollment | |
| II | 10 |
| III | 22 |
| IV | 8 |
| Time from aGVHD onset to day 1 of BV, median (range) | 31 d (6-185) |
| Time from day 0 of HCT (or DLI) to day 1 of BV, median (range) | 88 d (28-371) |
| Category of SR-aGVHD | |
| Progressing or not improving on initial steroids | 25 |
| Flare upon steroid tapering | 9 |
| BV dose level | |
| 0.6 mg/kg IV weekly × 3 | 3 |
| 0.9 mg/kg IV weekly × 3 | 3 |
| 0.6 mg/kg IV every other week × 4 | 10 |
| 0.8 mg/kg IV every other week × 4 | 18 |
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; DLI, donor leukocyte infusion; F, female; M, male; MDS, myelodysplastic syndrome; MMF, mycophenolate mofetil; MPN, myeloproliferative neoplasm; MTX, methotrexate; NHL, non-Hodgkin lymphoma.
Other diagnoses: aplastic anemia, blastic plasmacytoid dendritic cell neoplasm, chronic myelomonocytic leukemia.
Other GVHD prophylaxis: 3, ATG; 1, ATG or placebo; 1, bortezomib; 1, Milatuzumab; 1, RGI-2001.