Patient characteristics
| Characteristic . | Treatment arm . | ||||
|---|---|---|---|---|---|
| Etanercept (N = 29) . | MMF (N = 29) . | Denileukin diftitox (N = 26) . | Pentostatin (N = 28) . | Total (N = 112) . | |
| Female sex | 10 (34) | 11 (38) | 9 (35) | 12 (43) | 42 (38) |
| Median age, y (range) | 52 (20-70) | 45 (13-63) | 49 (11-65) | 55 (35-68) | 51 (11-70) |
| Disease | |||||
| AML/MDS | 16 (55) | 13 (45) | 12 (46) | 12 (43) | 53 (47) |
| ALL | 3 (10) | 5 (17) | 2 (7) | 5 (18) | 15 (13) |
| CML | 0 (0) | 2 (7) | 1 (4) | 0 (0) | 3 (3) |
| Lymphoma | 3 (10) | 4 (14) | 3 (1) | 3 (11) | 13 (12) |
| Other | 7 (24) | 5 (17) | 8 (31) | 8 (29) | 28 (25) |
| Conditioning regimen | |||||
| Myeloablative | 18 (62) | 24 (83) | 13 (50) | 14 (50) | 69 (62) |
| Nonmyeloablative | 11 (38) | 5 (17) | 13 (50) | 14 (50) | 43 (38) |
| Donor type | |||||
| Related | 13 (45) | 16 (55) | 9 (35) | 12 (43) | 50 (45) |
| Unrelated | 16 (55) | 13 (45) | 17 (65) | 16 (57) | 62 (55) |
| Stem cell source | |||||
| Bone marrow | 4 (14) | 11 (38) | 11 (42) | 7 (25) | 33 (30) |
| Peripheral blood | 21 (72) | 17 (59) | 7 (27) | 18 (64) | 63 (56) |
| Umbilical cord blood | 4 (14) | 1 (3) | 8 (31) | 3 (11) | 16 (14) |
| MMF prophylaxis | |||||
| Yes | 9 (31) | 0 (0) | 12 (46) | 7 (25) | 28 (25) |
| No | 20 (69) | 29 (100) | 14 (54) | 21 (75) | 84 (75) |
| Median days from transplantation to randomization (range) | 30 (13-147) | 29 (17-87) | 35 (14-80) | 36 (12-97) | 32 (12-147) |
| Enrollment acute GVHD | |||||
| Grade I/II | 24 (83) | 20 (693) | 18 (69) | 21 (75) | 83 (74) |
| Grade III/IV | 5 (17) | 9 (31) | 8 (31) | 7 (25) | 29 (26) |
| Organ involvement at randomization | |||||
| Skin | 25 (86) | 23 (79) | 20 (77) | 24 (86) | 92 (82) |
| GI tract (lower) | 7 (24) | 7 (24) | 7 (27) | 10 (36) | 31 (28) |
| GI tract (upper) | 4 (14) | 9 (31) | 8 (31) | 8 (29) | 29 (26) |
| Liver | 4 (14) | 6 (21) | 3 (11) | 3 (11) | 16 (14) |
| Response to treatment at day 28 | |||||
| CR/PR | 17 (59) | 22 (76) | 22 (85) | 20 (71) | 81 (72) |
| NR | 12 (41) | 7 (24) | 4 (15) | 8 (29) | 31 (28) |
| Survival status at day 180 | |||||
| Alive | 20 (69) | 21 (72) | 19 (73) | 17 (61) | 77 (69) |
| Dead | 9 (31) | 8 (28) | 7 (27) | 11 (39) | 35 (31) |
| Characteristic . | Treatment arm . | ||||
|---|---|---|---|---|---|
| Etanercept (N = 29) . | MMF (N = 29) . | Denileukin diftitox (N = 26) . | Pentostatin (N = 28) . | Total (N = 112) . | |
| Female sex | 10 (34) | 11 (38) | 9 (35) | 12 (43) | 42 (38) |
| Median age, y (range) | 52 (20-70) | 45 (13-63) | 49 (11-65) | 55 (35-68) | 51 (11-70) |
| Disease | |||||
| AML/MDS | 16 (55) | 13 (45) | 12 (46) | 12 (43) | 53 (47) |
| ALL | 3 (10) | 5 (17) | 2 (7) | 5 (18) | 15 (13) |
| CML | 0 (0) | 2 (7) | 1 (4) | 0 (0) | 3 (3) |
| Lymphoma | 3 (10) | 4 (14) | 3 (1) | 3 (11) | 13 (12) |
| Other | 7 (24) | 5 (17) | 8 (31) | 8 (29) | 28 (25) |
| Conditioning regimen | |||||
| Myeloablative | 18 (62) | 24 (83) | 13 (50) | 14 (50) | 69 (62) |
| Nonmyeloablative | 11 (38) | 5 (17) | 13 (50) | 14 (50) | 43 (38) |
| Donor type | |||||
| Related | 13 (45) | 16 (55) | 9 (35) | 12 (43) | 50 (45) |
| Unrelated | 16 (55) | 13 (45) | 17 (65) | 16 (57) | 62 (55) |
| Stem cell source | |||||
| Bone marrow | 4 (14) | 11 (38) | 11 (42) | 7 (25) | 33 (30) |
| Peripheral blood | 21 (72) | 17 (59) | 7 (27) | 18 (64) | 63 (56) |
| Umbilical cord blood | 4 (14) | 1 (3) | 8 (31) | 3 (11) | 16 (14) |
| MMF prophylaxis | |||||
| Yes | 9 (31) | 0 (0) | 12 (46) | 7 (25) | 28 (25) |
| No | 20 (69) | 29 (100) | 14 (54) | 21 (75) | 84 (75) |
| Median days from transplantation to randomization (range) | 30 (13-147) | 29 (17-87) | 35 (14-80) | 36 (12-97) | 32 (12-147) |
| Enrollment acute GVHD | |||||
| Grade I/II | 24 (83) | 20 (693) | 18 (69) | 21 (75) | 83 (74) |
| Grade III/IV | 5 (17) | 9 (31) | 8 (31) | 7 (25) | 29 (26) |
| Organ involvement at randomization | |||||
| Skin | 25 (86) | 23 (79) | 20 (77) | 24 (86) | 92 (82) |
| GI tract (lower) | 7 (24) | 7 (24) | 7 (27) | 10 (36) | 31 (28) |
| GI tract (upper) | 4 (14) | 9 (31) | 8 (31) | 8 (29) | 29 (26) |
| Liver | 4 (14) | 6 (21) | 3 (11) | 3 (11) | 16 (14) |
| Response to treatment at day 28 | |||||
| CR/PR | 17 (59) | 22 (76) | 22 (85) | 20 (71) | 81 (72) |
| NR | 12 (41) | 7 (24) | 4 (15) | 8 (29) | 31 (28) |
| Survival status at day 180 | |||||
| Alive | 20 (69) | 21 (72) | 19 (73) | 17 (61) | 77 (69) |
| Dead | 9 (31) | 8 (28) | 7 (27) | 11 (39) | 35 (31) |
All values are presented as N (%).
AML indicates acute myeloid leukemia; MDS, myelodysplastic syndrome; ALL, acute lymphocytic leukemia; CML, chronic myelogenous leukemia; MMF, mycophenolate mofetil; GI, gastrointestinal; CR, complete response; PR, partial response; and NR, nonresponse.