Patient characteristics
| Characteristic . | Treatment arm . | ||||
|---|---|---|---|---|---|
| Etanercept, n = 46 . | Mycophenolate, n = 45 . | Denileukin, n = 47 . | Pentostatin, n = 42 . | Total, n = 180 . | |
| Female sex | 16 (35) | 17 (38) | 19 (40) | 15 (36) | 67 (37) |
| Median age, y (range) | 50 (8-70) | 42 (13-63) | 51 (11-67) | 53 (24-68) | 50 (8-70) |
| Primary disease | |||||
| AML/MDS | 24 (52) | 21 (47) | 24 (51) | 20 (48) | 89 (50) |
| ALL | 6 (13) | 9 (20) | 4 (9) | 7 (17) | 26 (14) |
| CML | 2 (4) | 2 (4) | 1 (2) | 0 (0) | 5 (3) |
| Lymphoma | 5 (11) | 6 (13) | 8 (17) | 6 (14) | 25 (14) |
| Other | 9 (20) | 7 (16) | 10 (21) | 9 (21) | 35 (19) |
| Conditioning regimen | |||||
| Myeloablative | 29 (63) | 37 (82) | 25 (54) | 26 (63) | 117 (66) |
| Nonmyeloablative | 17 (37) | 8 (18) | 21 (46) | 15 (37) | 61 (34) |
| Donor status | |||||
| Related | 21 (47) | 24 (53) | 21 (46) | 17 (42) | 83 (47) |
| Unrelated | 24 (53) | 21 (47) | 25 (54) | 24 (58) | 94 (53) |
| Stem cell type | |||||
| Bone marrow | 5 (11) | 13 (29) | 15 (33) | 9 (22) | 42 (25) |
| Peripheral blood | 36 (78) | 29 (64) | 19 (41) | 27 (66) | 111 (61) |
| Umbilical cord blood | 5 (11) | 3 (7) | 12 (26) | 5 (12) | 25 (14) |
| MMF prophylaxis | |||||
| Yes | 14 (30) | 0 (0) | 16 (34) | 14 (33) | 44 (24) |
| No | 32 (70) | 45 (100) | 31 (66) | 28 (67) | 136 (76) |
| Median days from transplantation to randomization (range) | 30 (13-147) | 30 (13-87) | 35 (13-139) | 29 (12-97) | 30 (12-147) |
| Enrollment acute GVHD | |||||
| Grade 0 (range) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) |
| Grade I (range) | 8 (17) | 3 (7) | 8 (17) | 4 (10) | 23 (13) |
| Grade II (range) | 25 (54) | 25 (56) | 23 (49) | 26 (62) | 99 (55) |
| Grade III (range) | 12 (26) | 16 (36) | 15 (32) | 11 (26) | 54 (30) |
| Grade IV (range) | 0 (0) | 1 (2) | 1 (2) | 1 (2) | 3 (2) |
| Organ involvement at randomization | |||||
| Skin | 36 (78) | 35 (78) | 35 (75) | 34 (81) | 140 (78) |
| GI tract, lower | 12 (26) | 18 (40) | 14 (30) | 17 (41) | 61 (34) |
| GI tract, upper | 10 (22) | 12 (27) | 14 (30) | 13 (31) | 49 (27) |
| Liver | 6 (13) | 7 (16) | 7 (15) | 5 (12) | 25 (14) |
| Characteristic . | Treatment arm . | ||||
|---|---|---|---|---|---|
| Etanercept, n = 46 . | Mycophenolate, n = 45 . | Denileukin, n = 47 . | Pentostatin, n = 42 . | Total, n = 180 . | |
| Female sex | 16 (35) | 17 (38) | 19 (40) | 15 (36) | 67 (37) |
| Median age, y (range) | 50 (8-70) | 42 (13-63) | 51 (11-67) | 53 (24-68) | 50 (8-70) |
| Primary disease | |||||
| AML/MDS | 24 (52) | 21 (47) | 24 (51) | 20 (48) | 89 (50) |
| ALL | 6 (13) | 9 (20) | 4 (9) | 7 (17) | 26 (14) |
| CML | 2 (4) | 2 (4) | 1 (2) | 0 (0) | 5 (3) |
| Lymphoma | 5 (11) | 6 (13) | 8 (17) | 6 (14) | 25 (14) |
| Other | 9 (20) | 7 (16) | 10 (21) | 9 (21) | 35 (19) |
| Conditioning regimen | |||||
| Myeloablative | 29 (63) | 37 (82) | 25 (54) | 26 (63) | 117 (66) |
| Nonmyeloablative | 17 (37) | 8 (18) | 21 (46) | 15 (37) | 61 (34) |
| Donor status | |||||
| Related | 21 (47) | 24 (53) | 21 (46) | 17 (42) | 83 (47) |
| Unrelated | 24 (53) | 21 (47) | 25 (54) | 24 (58) | 94 (53) |
| Stem cell type | |||||
| Bone marrow | 5 (11) | 13 (29) | 15 (33) | 9 (22) | 42 (25) |
| Peripheral blood | 36 (78) | 29 (64) | 19 (41) | 27 (66) | 111 (61) |
| Umbilical cord blood | 5 (11) | 3 (7) | 12 (26) | 5 (12) | 25 (14) |
| MMF prophylaxis | |||||
| Yes | 14 (30) | 0 (0) | 16 (34) | 14 (33) | 44 (24) |
| No | 32 (70) | 45 (100) | 31 (66) | 28 (67) | 136 (76) |
| Median days from transplantation to randomization (range) | 30 (13-147) | 30 (13-87) | 35 (13-139) | 29 (12-97) | 30 (12-147) |
| Enrollment acute GVHD | |||||
| Grade 0 (range) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) |
| Grade I (range) | 8 (17) | 3 (7) | 8 (17) | 4 (10) | 23 (13) |
| Grade II (range) | 25 (54) | 25 (56) | 23 (49) | 26 (62) | 99 (55) |
| Grade III (range) | 12 (26) | 16 (36) | 15 (32) | 11 (26) | 54 (30) |
| Grade IV (range) | 0 (0) | 1 (2) | 1 (2) | 1 (2) | 3 (2) |
| Organ involvement at randomization | |||||
| Skin | 36 (78) | 35 (78) | 35 (75) | 34 (81) | 140 (78) |
| GI tract, lower | 12 (26) | 18 (40) | 14 (30) | 17 (41) | 61 (34) |
| GI tract, upper | 10 (22) | 12 (27) | 14 (30) | 13 (31) | 49 (27) |
| Liver | 6 (13) | 7 (16) | 7 (15) | 5 (12) | 25 (14) |
ALL indicates acute lymphoblastic leukemia; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; and MDS, myelodysplastic syndromes.