Patient and transplant characteristics
| . | Adult (n = 10) . | Pediatric (n = 11) . | All (N = 21) . | P . |
|---|---|---|---|---|
| BMT to study, median (range), y | 3.6 (1-12.1) | 1.8 (1-4.5) | 2.4 (1-12.1) | .07 |
| cGVHD onset to study, median (range), y | 2.0 (0.1-11.8) | 1.1 (0.1-3) | 1.5 (0.1-11.8) | .17 |
| No. of cGVHD sites involved, median (range) | 3.5 (1-6) | 3 (1-4) | 3 (1-6) | .58 |
| No. of prior cGVHD therapies, median (range) | 3 (1-6) | 2 (1-4) | 2 (1-6) | .11 |
| NIH consensus global cGVHD severity, n (%) | .34 | |||
| Mild | 1 (10) | 0 (0) | 1 (5) | |
| Moderate | 5 (50) | 9 (82) | 14 (67) | |
| Severe | 4 (40) | 2 (18) | 6 (28) | |
| Daily prednisone dose at enrollment, median (range), mg/kg* | 0.3 (0-0.6) | 0.5 (0-1) | 0.3 (0-1) | .06 |
| Prior grade I-IV acute GVHD, n (%) | 6 (60) | 6 (54.5) | 12 (57.1) | 1.0 |
| Age, median (range), y | 57 (33-71) | 12 (2-23) | 23 (2-71) | <.0001 |
| Patient sex, n (%) | .36 | |||
| Male | 6 (60) | 9 (81.8) | 15 (71.4) | |
| Female | 4 (40) | 2 (18.2) | 6 (28.6) | |
| Primary disease, n (%) | .11 | |||
| AML | 2 (20) | 2 (18.2) | 4 (19.0) | |
| CLL | 2 (20) | 0 (0) | 2 (9.5) | |
| CML | 1 (10) | 0 (0) | 1 (4.8) | |
| Hodgkin disease | 1 (10) | 0 (0) | 1 (4.8) | |
| Anemia/red cell disorder | 0 (0) | 2 (18.2) | 2 (9.5) | |
| Immunodeficiency | 0 (0) | 1 (9.1) | 1 (4.8) | |
| ALL | 0 (0) | 5 (45.6) | 5 (23.8) | |
| MDS | 1 (10) | 1 (9.1) | 2 (9.5) | |
| NHL | 3 (30) | 0 (0) | 3 (14.3) | |
| Conditioning regimen intensity, n (%) | .002 | |||
| Myeloablative | 2 (20) | 10 (90.9) | 12 (57.1) | |
| Nonmyeloablative | 8 (80) | 1 (9.1) | 9 (42.9) | |
| HLA molecular typing (A, B, C, DRB1), n (%) | .16 | |||
| Matched unrelated | 8 (80) | 5 (45.4) | 13 (61.9) | |
| Matched related | 2 (20) | 3 (27.3) | 5 (23.8) | |
| Mismatch unrelated | 0 (0) | 3 (27.3) | 3 (14.3) | |
| Patient or donor CMV serostatus, n (%) | .15 | |||
| Positive | 1 (10) | 5 (45.5) | 6 (28.6) | |
| Graft source, n (%) | <.0001 | |||
| Bone marrow | 0 (0) | 11 (100) | 11 (52.4) | |
| PBSC | 10 (100) | 0 (0) | 10 (47.6) |
| . | Adult (n = 10) . | Pediatric (n = 11) . | All (N = 21) . | P . |
|---|---|---|---|---|
| BMT to study, median (range), y | 3.6 (1-12.1) | 1.8 (1-4.5) | 2.4 (1-12.1) | .07 |
| cGVHD onset to study, median (range), y | 2.0 (0.1-11.8) | 1.1 (0.1-3) | 1.5 (0.1-11.8) | .17 |
| No. of cGVHD sites involved, median (range) | 3.5 (1-6) | 3 (1-4) | 3 (1-6) | .58 |
| No. of prior cGVHD therapies, median (range) | 3 (1-6) | 2 (1-4) | 2 (1-6) | .11 |
| NIH consensus global cGVHD severity, n (%) | .34 | |||
| Mild | 1 (10) | 0 (0) | 1 (5) | |
| Moderate | 5 (50) | 9 (82) | 14 (67) | |
| Severe | 4 (40) | 2 (18) | 6 (28) | |
| Daily prednisone dose at enrollment, median (range), mg/kg* | 0.3 (0-0.6) | 0.5 (0-1) | 0.3 (0-1) | .06 |
| Prior grade I-IV acute GVHD, n (%) | 6 (60) | 6 (54.5) | 12 (57.1) | 1.0 |
| Age, median (range), y | 57 (33-71) | 12 (2-23) | 23 (2-71) | <.0001 |
| Patient sex, n (%) | .36 | |||
| Male | 6 (60) | 9 (81.8) | 15 (71.4) | |
| Female | 4 (40) | 2 (18.2) | 6 (28.6) | |
| Primary disease, n (%) | .11 | |||
| AML | 2 (20) | 2 (18.2) | 4 (19.0) | |
| CLL | 2 (20) | 0 (0) | 2 (9.5) | |
| CML | 1 (10) | 0 (0) | 1 (4.8) | |
| Hodgkin disease | 1 (10) | 0 (0) | 1 (4.8) | |
| Anemia/red cell disorder | 0 (0) | 2 (18.2) | 2 (9.5) | |
| Immunodeficiency | 0 (0) | 1 (9.1) | 1 (4.8) | |
| ALL | 0 (0) | 5 (45.6) | 5 (23.8) | |
| MDS | 1 (10) | 1 (9.1) | 2 (9.5) | |
| NHL | 3 (30) | 0 (0) | 3 (14.3) | |
| Conditioning regimen intensity, n (%) | .002 | |||
| Myeloablative | 2 (20) | 10 (90.9) | 12 (57.1) | |
| Nonmyeloablative | 8 (80) | 1 (9.1) | 9 (42.9) | |
| HLA molecular typing (A, B, C, DRB1), n (%) | .16 | |||
| Matched unrelated | 8 (80) | 5 (45.4) | 13 (61.9) | |
| Matched related | 2 (20) | 3 (27.3) | 5 (23.8) | |
| Mismatch unrelated | 0 (0) | 3 (27.3) | 3 (14.3) | |
| Patient or donor CMV serostatus, n (%) | .15 | |||
| Positive | 1 (10) | 5 (45.5) | 6 (28.6) | |
| Graft source, n (%) | <.0001 | |||
| Bone marrow | 0 (0) | 11 (100) | 11 (52.4) | |
| PBSC | 10 (100) | 0 (0) | 10 (47.6) |
ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; BMT, bone marrow transplantation; CLL, chronic lymphocytic leukemia; CML, chronic myelogenous leukemia; CMV, cytomegalovirus; MDS, myelodysplastic syndrome; NHL, non-Hodgkin lymphoma; NIH, National Institutes of Health; PBSC, peripheral blood stem cell.
One pediatric patient and 1 adult patient were SR but were already weaned off systemic steroids at study entry.