Subject characteristics
. | Randomized treatment arm . | . | . | ||
|---|---|---|---|---|---|
| Baseline characteristics . | Steroids + placebo; n = 49 . | Steroids + daclizumab; n = 53 . | P* . | ||
| Median age, y (range) | 42 (18-59) | 45 (8-65) | .65 | ||
| Institution, no. (%) | .69 | ||||
| Baylor | 14 (29) | 10 (19) | |||
| DFCI/BWH | 25 (51) | 32 (60) | |||
| MINN | 7 (14) | 8 (15) | |||
| OHSU | 3 (6) | 2 (4) | |||
| RPCI | 0 (0) | 1 (2) | |||
| Donor/patient sex, no. (%) | .82 | ||||
| Male/male | 14 (29) | 19 (36) | |||
| Male/female | 13 (27) | 11 (21) | |||
| Female/female | 12 (24) | 11 (21) | |||
| Female/male | 10 (20) | 12 (22) | |||
| Donor/patient CMV, no. (%) | .37 | ||||
| —/— | 17 (35) | 20 (38) | |||
| —/— | 8 (16) | 8 (15) | |||
| —/+ | 13 (27) | 11 (21) | |||
| —/+ | 5 (10) | 13 (24) | |||
| Unknown | 6 (12) | 1 (2) | |||
| Type of transplant, no. (%) | .66 | ||||
| Matched related | 19 (39) | 21 (40) | |||
| Matched unrelated | 20 (41) | 23 (43) | |||
| Mismatched related | 1 (2) | 3 (6) | |||
| Mismatched unrelated | 9 (18) | 6 (11) | |||
| Source of progenitor cells, no. (%) | .61 | ||||
| Bone marrow | 8 (16) | 13 (25) | |||
| PBSC | 35 (72) | 35 (66) | |||
| Cord | 6 (12) | 5 (9) | |||
| Risk group, no. (%)† | .56 | ||||
| Good | 12 (24) | 12 (22) | |||
| Intermediate | 21 (43) | 28 (53) | |||
| Poor | 16 (33) | 13 (25) | |||
| Nonmyeloablative transplant, no. (%) | .56 | ||||
| Yes | 5 (10) | 8 (15) | |||
| No | 44 (90) | 45 (85) | |||
| T-cell depletion, n (%) | 9 (18) | 10 (19) | .99 | ||
| Acute GVHD grade at time of study entry, no. (%) | .47 | ||||
| I | 10 (20) | 11 (21) | |||
| II | 27 (55) | 34 (64) | |||
| III-IV | 12 (25) | 8 (15) | |||
| Organ involvement at time of study entry, no. (%) | |||||
| Skin | 48 (98) | 59 (98) | .99 | ||
| Liver | 16 (33) | 20 (38) | .68 | ||
| Gastrointestinal | 19 (39) | 28 (53) | .17 | ||
| Median time from HSCT to study day 0, d (range) | 20 (8-63) | 23 (6-90) | .36 | ||
. | Randomized treatment arm . | . | . | ||
|---|---|---|---|---|---|
| Baseline characteristics . | Steroids + placebo; n = 49 . | Steroids + daclizumab; n = 53 . | P* . | ||
| Median age, y (range) | 42 (18-59) | 45 (8-65) | .65 | ||
| Institution, no. (%) | .69 | ||||
| Baylor | 14 (29) | 10 (19) | |||
| DFCI/BWH | 25 (51) | 32 (60) | |||
| MINN | 7 (14) | 8 (15) | |||
| OHSU | 3 (6) | 2 (4) | |||
| RPCI | 0 (0) | 1 (2) | |||
| Donor/patient sex, no. (%) | .82 | ||||
| Male/male | 14 (29) | 19 (36) | |||
| Male/female | 13 (27) | 11 (21) | |||
| Female/female | 12 (24) | 11 (21) | |||
| Female/male | 10 (20) | 12 (22) | |||
| Donor/patient CMV, no. (%) | .37 | ||||
| —/— | 17 (35) | 20 (38) | |||
| —/— | 8 (16) | 8 (15) | |||
| —/+ | 13 (27) | 11 (21) | |||
| —/+ | 5 (10) | 13 (24) | |||
| Unknown | 6 (12) | 1 (2) | |||
| Type of transplant, no. (%) | .66 | ||||
| Matched related | 19 (39) | 21 (40) | |||
| Matched unrelated | 20 (41) | 23 (43) | |||
| Mismatched related | 1 (2) | 3 (6) | |||
| Mismatched unrelated | 9 (18) | 6 (11) | |||
| Source of progenitor cells, no. (%) | .61 | ||||
| Bone marrow | 8 (16) | 13 (25) | |||
| PBSC | 35 (72) | 35 (66) | |||
| Cord | 6 (12) | 5 (9) | |||
| Risk group, no. (%)† | .56 | ||||
| Good | 12 (24) | 12 (22) | |||
| Intermediate | 21 (43) | 28 (53) | |||
| Poor | 16 (33) | 13 (25) | |||
| Nonmyeloablative transplant, no. (%) | .56 | ||||
| Yes | 5 (10) | 8 (15) | |||
| No | 44 (90) | 45 (85) | |||
| T-cell depletion, n (%) | 9 (18) | 10 (19) | .99 | ||
| Acute GVHD grade at time of study entry, no. (%) | .47 | ||||
| I | 10 (20) | 11 (21) | |||
| II | 27 (55) | 34 (64) | |||
| III-IV | 12 (25) | 8 (15) | |||
| Organ involvement at time of study entry, no. (%) | |||||
| Skin | 48 (98) | 59 (98) | .99 | ||
| Liver | 16 (33) | 20 (38) | .68 | ||
| Gastrointestinal | 19 (39) | 28 (53) | .17 | ||
| Median time from HSCT to study day 0, d (range) | 20 (8-63) | 23 (6-90) | .36 | ||
DFCI indicates Dana-Farber Cancer Institute; BWH, Brigham and Women's Hospital; MINN, University of Minnesota; OHSU, Oregon Health and Science University; and RPCI, Roswell Park Cancer Institute.
Unknown values were not used in the calculation of the P values
Good risk indicates CML in first chronic phase (CP1), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) in complete response 1 (CR1), aplastic anemia. Intermediate risk indicates CML in accelerated phase (AP); AML and ALL in CR2 or above; non-Hodgkin lymphoma (NHL), multiple myeloma (MM), Hodgkin disease (HD) in partial response (PR); plus everyone else not good or poor. Poor risk indicates refractory or relapsed disease