Table 1.
| A Patient and Transplantation Characteristics | |||||||
|---|---|---|---|---|---|---|---|
| Cohort 1, n = 127 |
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| Discovery Samples, n = 20 |
Validation Samples, n = 127 |
Cohort 2, n = 22 |
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| Upper-gut GVHD, n = 5 |
Mid-gut GVHD, n = 5 |
GVHD− n = 10 | GVHD+ n = 78 | GVHD− n = 49 | GVHD+ n = 14 | GVHD− n = 8 | |
| Patient age, median (range), yr | 42 (18 to 48) | 49 (22 to 59) | 39 (37 to 58) | 43 (18 to 67) | 45 (19 to 65) | 45 (28 to 62) | 39 (30 to 58) |
| Diagnosis | |||||||
| Acute leukemia | 2 | 4 | 6 | 40 | 19 | 9 | 3 |
| MDS | 2 | 1 | 2 | 17 | 14 | 1 | 4 |
| Lymphoma | 0 | 0 | 0 | 7 | 4 | 1 | 1 |
| Chronic leukemia (CLL, CML) | 1 | 0 | 2 | 13 | 11 | 3 | 0 |
| Other | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Donor type | |||||||
| Related | 3 | 2 | 7 | 33 | 31 | 5 | 3 |
| Unrelated | 2 | 3 | 3 | 45 | 18 | 9 | 5 |
| Sex match | |||||||
| Female to male/Other | 2/3 | 4/1 | 2/8 | 18/60 | 15/34 | 3/11 | 1/7 |
| Graft type | |||||||
| Marrow/Blood/Cord | 0/5 | 0/5 | 1/9/0 | 6/72/0 | 3/46/0 | 2/12/0 | 2/5/1 |
| Conditioning regimen | |||||||
| Myeloablative | 5 | 5 | 10 | 77 | 48 | 7 | 5 |
| TBI >1000 cGy | 1 | 3 | 4 | 32 | 9 | 7 | 3 |
| Reduced intensity | 0 | 0 | 0 | 1 | 1 | 7 | 3 |
| CMV seropositive | |||||||
| Patient/Donor | 3/1 | 4/2 | 2/1 | 41/31 | 18/16 | 9/6 | 3/1 |
| GVHD prophylaxis | |||||||
| CNI + MTX | 4 | 5 | 9 | 72 | 44 | 10 | 7 |
| CNI + MMF | 1 | 0 | 1 | 4 | 2 | 1 | 1 |
| CNI + MTX + Sirolimus | 0 | 0 | 0 | 2 | 3 | 2 | 0 |
| CNI + MTX + Campath | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Acute GVHD onset, median (range), d |
36 (23 to 43) | 43 (23 to 52) | NA | 27 (7 to 64) | NA | 31 (16 to 65) | NA |
| Acute GVHD | |||||||
| Grade 0 | 0 | 0 | 10 | 0 | 49 | 0 | 7 |
| Grade 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 | 4 | 0 | 0 | 63 | 0 | 10 | 0 |
| Grade 3 | 1 | 5 | 0 | 13 | 0 | 3 | 0 |
| Grade 4 | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
| Organ-specific acute GVHD* | |||||||
| Mid-gut | 0 | 5 | 0 | 15 | 0 | 3 | 0 |
| Upper-gut | 5 | 0 | 0 | 63 | 0 | 10 | 0 |
| Skin only | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Liver only | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B Concurrent Involvement of Skin, Liver, and Gut GVHD | ||||||
|---|---|---|---|---|---|---|
| Clinically Significant Grade 2 to 4 Acute GVHD |
||||||
| Skin Only |
Liver Only |
Gut Only |
Gut/ Skin |
Gut/ Liver |
Gut/Liver/ Skin |
|
| GVHD+ cohort 1 | 0 | 0 | 43 | 17 | 7 | 11 |
| GVHD+ cohort 2 | 1 | 0 | 5 | 5 | 1 | 2 |
| GVHD+ discovery samples* |
0 | 0 | 2 | 4 | 2 | 2 |
GVHD indicates graft-versus-host disease; CLL, chronic lymphocytic leukemia; CML, chronic myelogenous leukemia; MDS, myelodysplastic syndrome; TBI, total body irradiation; CNI, calcinuerin inhibitor; MTX, methotrexate.
*
Grade 2 to 4 acute GVHD.
GVHD indicates graft-versus-host disease.
*
Cohort 1 GVHD+ cases selected for the initial pooled plasma discovery analysis.