Table 1.
Patient’s with cGVHD characteristics at the time of enrollment
| Patient characteristics | n (%) or (range) |
|---|---|
| Total number of patients | 187 |
| Age (median, range) | 46 (4–70) |
| Gender | |
| Male | 103 (55 %) |
| Female | 85 (45 %) |
| Disease | |
| ALL/AML/MDS | 79 (46 %) |
| Lymphoma/CML/MM | 71 (41 %) |
| CLL | 12 (7 %) |
| Aplastic Anemia/PNH | 6 (4 %) |
| Other non-malignant | 3 (2 %) |
| Conditioning regimen | |
| Myeloblative | 106 (57 %) |
| Total Body Irradiation (TBI) | 72 (39 %) |
| Donor relationship | |
| Unrelated | 72 (39%) |
| Related | 113 (61 %) |
| Cell source | |
| Bone Marrow | 35 (19 %) |
| Peripheral Blood | 146 (79 %) |
| Cord Blood | 4 (2 %) |
| HLA match | |
| Yes | 148 (82 %) |
| No | 32 (18 %) |
| cGVHD onset type | |
| Progressive | 70 (38 %) |
| Quiescent | 52 (29 %) |
| De Novo | 60 (33 %) |
| Activity by therapeutic intent a | |
| Active | 79 (53 %) |
| Not Active | 69 (47 %) |
| Unknown (other) | 50 (25 %) |
| Intensity of immunosuppression b | |
| None/mild | 46 (25 %) |
| Moderate | 62 (34 %) |
| Severe | 75 (41 %) |
| NIH average total number of organs involved | 5 |
| Mouth | 135 (68%) |
| Skin | 145 (79%) |
| Eyes | 148 (80 %) |
| Lung | 141 (77%) |
| Liver | 96 (52%) |
| Joints or Fascia | 115 (63%) |
| Genitourinary Tract | 42(50%) |
| Gastrointestinal Tract | 84 (46%) |
| NIH Average Score | 1.0(0–2.33) |
| NIH Global Score | |
| Mild | 3 (2%) |
| Moderate | 59 (30%) |
| Severe | 134 (68%) |
| Median number of months from transplant to enrollment | 51 (4–258) |
For all values in above table, continuous variables are shown as median values with ranges and categorical variables are shown as frequencies with percentages.
Abbreviations: ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; MDS, myelodysplastic syndrome; CML, chronic myeloid leukemia; CLL, chronic lymphocytic leukemia; MM, Multiple Myeloma PNH, paroxysmal nocturnal hemoglobinuria; M, male; F, female; HLA, human leukocyte antigen.
active: 1) increase systemic therapy because cGVHD is worse; 2) substitute systemic therapy due to lack of response; and 3) withdraw systemic therapy due to lack of response. Non-active: 1) decrease systemic therapy because cGVHD is better; 2) not change current systemic therapy because cGVHD is stable;
Intensity of Immunosupression: Mild, single agent prednisone < 0.5; Moderate, prednisone ≥ 0.5mg/kg/day and/or any singe agent/modality; High, 2 or more agents/modalities ± prednisone ≥ 0.5mg/kg/day.