Table 1.
Baseline demographics and clinical characteristics of the study participants and controls.
| Characteristic | Study | Control | P value | |
|---|---|---|---|---|
| No. (%) or Median (IQR) | No. (%) or Median (IQR) | |||
| Age (years) | 51 (30) | 56 (12) | 0.10 | |
| Gender | Male | 26 (76) | 18 (64) | 0.44 |
| Female | 8 (24) | 10 (36) | ||
| Race/Ethnicity | White | 30 (88) | 24 (86) | 0.54 |
| Black or African American | – | 1 (4) | ||
| Other† | 4 (12) | 3 (11) | ||
| Diagnosis | Malignant | 32 (94) | 28 (100) | 0.56 |
| Acute myelogenous leukemia | 13 (38) | 8 (29) | ||
| Acute lymphoblastic leukemia | 6 (18) | 7 (25) | ||
| Multiple myeloma | 4 (12) | 2 (7) | ||
| Myelodysplastic syndrome | 4 (12) | 3 (11) | ||
| Non-Hodgkin’s lymphoma | 2 (6) | 4 (14) | ||
| Myelofibrosis | 2 (6) | 1 (4) | ||
| Chronic lymphocytic leukemia | 1 (3) | 2 (7) | ||
| Chronic myelogenous leukemia | – | 1 (4) | ||
| Non-malignant disease | 2 (6) | – | ||
| Disease Risk Status | Low | 13 (38) | 11 (39) | 0.74 |
| Intermediate | 5 (15) | 6 (21) | ||
| High | 16 (47) | 11 (39) | ||
| Donor | Matched related | 12 (35) | 10 (36) | 0.46 |
| Matched unrelated | 16 (47) | 12 (43) | ||
| Mismatched related | – | 2 (7) | ||
| Mismatched unrelated | 6 (18) | 4 (14) | ||
| CMV Status | Recipient (R) or Donor (D) positive | 24 (71) | 20 (71) | 0.80 |
| R+, D+ | 9 (26) | 10 (36) | ||
| R+, D– | 12 (35) | 9 (32) | ||
| R–, D+ | 3 (9) | 1 (4) | ||
| Recipient and Donor negative | 10 (29) | 8 (29) | ||
| Conditioning | Full | 24 (71) | 21 (76) | 0.92 |
| Busulfan-based‡ | 20 (59) | 18 (65) | ||
| TBI-based§,£ | 3 (9) | 3 (11) | ||
| BCNU-based¶ | 1 (3) | – | ||
| Reduced | 10 (30) | 7 (25) | ||
| Fludarabine, busulfan | 6 (18) | 6 (21) | ||
| Fludarabine, melphalan | 3 (9) | 1 (4) | ||
| Cyclophosphamide, ATG | 1 (3) | – | ||
| CD34+ Count (×106 cells/kg) | 6.3 (2.2) | 5.7 (1.2) | 0.36 | |
| GVHD Prophylaxis | Calcineurin Inhibitor, MTX | 18 (53) | 13 (46) | 0.80 |
| Calcineurin Inhibitor, MMF | 16 (47) | 15 (54) | ||
| Time HSCT to Grade 1 acute GVHD Diagnosis (days) | 28 (35) | 32 (19) | 0.84 | |
| Time to Progression, Grade 1 to Grade 2–4 GVHD (days) | 24 (50) | 7 (27) | 0.08 | |
†
Study: Asian (n=1), Hispanic or Latino (n=3); Control: American Indian/Alaskan Native (n=1), Hispanic or Latino (n=2)
‡
Study:fludarabine and busulfan (n=14), clofarabine and busulfan (n=6); Control: fludarabine and busulfan (n=10), clofarabine and busulfan (n=8)
§
Study:cyclophosphamide and TBI (n=1), thiotepa, cyclophosphamide and TBI (n=1), campath, fludarabine, cyclophosphamide and TBI (n=1); Control: cyclophosphamide and TBI (n=3)
¶
Study: rituximab, carmustine, etoposide, cytarabine and melphalan (n=1)
£
Abbreviations: TBI, total body irradiation; BCNU, carmustine; MTX, mini-methotrexate; MMF, mycophenolatemofetil